Babita Yadav

Evaluation of Vyoshadi Guggulu and Haritaki Churna in the Management of Dyslipidemia: A Multicenter Prospective Clinical Study.

Introduction: Dyslipidemia (DL) is a principal risk factor in the pathophysiology of cardiovascular diseases (CVD) and diabetes mellitus (DM). It may correlate with Medoroga, which is a risk factor for diseases like Prameha, Hridroga Jwara, Bhagandara, Vrana, Vataroga, etc. Aim: To assess the clinical efficacy of Vyoshadi Guggulu (VG) and Haritaki Churna (HC) in the management of DL and changes in the quality of life of the study participants. Materials and methods: It was a prospective, multicenter, single-arm study. The Ayurvedic formulations VG (2 tablets of 500 mg each TDS) after food with lukewarm water and HC (3 gm bd) were administered for 12 weeks with a follow-up of 2 weeks without interventions. Totally, 146 participants belonging to either sex, 18 to 70 years with low-density lipoprotein (LDL) 100 to 160 mg/dL and/or serum cholesterol 200 to 250 mg/dL and/or serum triglycerides (TG) 150 to 250 mg/dL and those willing and able to participate were included in the study. The outcome measures were changes in lipid profile, clinical safety, and changes in the quality of life. Results: There was a significant reduction (p < 0.005) in the mean serum cholesterol level, i.e., 214.8 reduced to 208.3 after 84 days of treatment and (p < 0.001) in the mean high-density lipoprotein (HDL), i.e., 46.3 reduced to 44.04 after 84 days of treatment. There was no significant change in the serum TG, LDL, and very-low density lipoprotein (VLDL) value. There is also improvement in the quality of life (p < 0.001) of the participants. There are no significant changes observed in the laboratory safety parameters. This corroborated that drugs are safe to use. ReSeARch ARticle 1Director (Ayurveda), 2Assistant Director (Ayurveda), 3-8Research Officer (Ayurveda), 9Statistical Officer, 10Statistical Assistant 11Deputy Director General 1,4,6-11Central Council for Research in Ayurvedic Sciences, New Delhi, India 2National Ayurveda Research Institute for Panchakarma Cheruturuthy, Kerala, India 3 Regional Ayurveda Research Institute for Drug Development Gwalior, Madhya Pradesh, India 5Central Ayurveda Research Institute for Hepatobiliary Disorders, Bhubaneswar, Odisha, India Corresponding Author: Sarada Ota, Research Officer (Ayurveda), Central Council for Research in Ayurvedic Sciences New Delhi, India, Phone: +9101128525410, e-mail: sarada_ ota@yahoo.com Conclusion: Vyoshadi Guggulu and Haritaki Churna are effective in the management of DL and are safe to use. Clinical significance: The use of these drugs may lower the complications of DL.

Clinical Efficacy and Safety of Sarasvata Ghrita in the Management of Cognitive Deficit – A Prospective Open Label Study

Introduction: Cognitive deficit describes deficit in global intellectual performances. It is a condition which usually begins in childhood, and the patient shows significant limitations in their ability to learn and function. Its cause may be congenital or may occur due to environmental factors such as brain injuries, neurological disorders, or mental illness, etc. The cognitive deficit can be correlated with Budhimandyata in Ayurveda.

Clinical Safety of Selected Ayurvedic Formulations in Osteopenia/Osteoporosis

Introduction: Osteopenia/osteoporosis is a condition characterized by decrease in bone mineral density. It is a major public health problem especially for women in India. The clinical picture of osteopenia/osteoporosis is similar to the condition of Asthidhatukshaya described in Ayurveda which is characterized by the loss of saarata of Asthi dhatu leading to increased predisposition to other bone-related pathologies. Laksha Guggulu, Mukta-Shukti Pishti, Ashwagandha Churna, and Pravala Pishti are some of the most common medicines used in the management of osteopenia/osteoporosis. However, safety data are not collected on these formulations. Objective: To critically analyze and present clinical safety of classical Ayurvedic formulations, viz., Laksha Guggulu, Mukta-Shukti Pishti, Ashwagandha Churna, and Pravala Pishti in osteopenia/osteoporosis, through multicenter open-label studies at different Central Council for Research in Ayurvedic Sciences (CCRAS) centers. Materials and methods: Data were collected from two different clinical studies executed in peripheral institutes of CCRAS and critically analyzed to assess the safety of four formulations: Laksha Guggulu, Mukta-Shukti Pishti, Ashwagandha Churna, and Pravala Pishti in osteopenia/osteoporosis. Safety assessments were done through liver function tests [LFTs; serum glutamate pyruvate transaminase (SGPT), serum glutamate oxaloacetic transaminase (SGOT), alkaline phosphatase (ALP), serum protein, albumin, globulin, and bilirubin] and kidney function tests (KFTs; serum urea and serum creatinine) before and after the trial period. Drug compliance and adverse drug reaction/adverse events, if any, were noted. RESEARCH ARTICLE 1-7,9-11Research Officer (Ayurveda), 8,14Assistant Director (Ayurveda), 12Statistical Officer (Ayurveda), 13Statistical Assistant (Ayurveda), 15Former Deputy Director General (Ayurveda) 1-4,7,10-13,15Central Council for Research in Ayurvedic Sciences New Delhi, India 5,8Raja Ramdeo Anandilal Podar Central Ayurveda Research Institute for Cancer, Mumbai, Maharashtra, India 6,9Regional Ayurveda Research Institute for Metabolic Disorders Bengaluru, Karnataka, India 14Central Ayurveda Research Institute for Cardiovascular Diseases, New Delhi, India Corresponding Author: Sunita, Research Officer (Ayurveda) Central Council for Research in Ayurvedic Sciences, New Delhi India, Phone: +918010529320, e-mail: sunita.dr@rediffmail.com Conclusion: The finding in the two clinical studies indicated that Laksha Guggulu, Mukta-Shukti Pishti, Ashwagandha Churna, and Pravala Pishti are clinically safe, effective, and tolerable as participants belonging to different age groups, gender, geographical areas, and having different prakriti responded well to the trial medications without any adverse reactions or adverse events.

Clinical Safety of Selected Ayurvedic Formulations in Obesity and Dyslipidemia

Introduction: Obesity is a condition of abnormal or excessive fatness, and dyslipidemia is a condition with abnormal raised levels of any one or all lipids in the blood. Ayurveda compares signs and symptoms of obesity and dyslipidemia with the disease Sthaulya/Medoroga. Vyoshadi Guggulu and Haritaki Churna are the most commonly used medicines in the management of Sthaulya. However, the safety of these drugs was not evaluated until now through clinical trials. Objective: The objective of this study was to assess clinical safety of Vyoshadi Guggulu and Haritaki Churna in the management of obesity (Sthaulya) and dyslipidemia. Materials and methods: A prospective, open-label multicentric study was carried out at peripheral institutes of the Central Council for Research in Ayurvedic Sciences (CCRAS). Total 306 patients satisfying selection criteria were randomly selected from the outpatient department of respective centers and were administered Vyoshadi Guggulu (3 tablets of 500 mg) and Haritaki Churana (3 gm twice daily) in case of obesity, and Vyoshadi Guggulu (2 tablets of 500 mg thrice in a day) and Haritaki Churana (3 gm twice daily in cases of dyslipidemia) with lukewarm water for 12 weeks. So, the daily intake of the medicine was similar in all these cases. Hematological paraReSeARch ARticle 1-7,13,14Research Officer (Ayurveda), 8Former Assistant Director (Ayurveda), 9Director (Ayurveda), 10-12Assistant Director (Ayurveda), 15Statistical Officer (Ayurveda) 1-5,14,15Central Council for Research in Ayurvedic Sciences, New Delhi, India 6,13Regional Ayurveda Research Institute for Metabolic Disorders Bengaluru, Karnataka, India 7Central Ayurveda Research Institute for Drug Development Kolkata, West Bengal, India 8,11Central Ayurveda Research Institute for Neuromuscular & Musculo-Skeletal Disorders, Cheruthuruthy, Kerala, India 9Central Ayurveda Research Institute for Hepatobiliary Disorders Bhubaneswar, Odisha, India 10Central Council for Research in Ayurvedic Sciences, Patiala Punjab, India 12Regional Ayurveda Research Institute for Drug Development Gwalior, Madhya Pradesh, India Corresponding Author: Bhagwan S Sharma, Research Officer (Ayurveda), Central Council for Research in Ayurvedic Sciences New Delhi, India, Phone: +919968485854, e-mail: bss_ro@ rediffmail.com meters, viz., lipid profile, and safety parameters were assessed at baseline and at the end of 12 weeks. Paired sample t-test was applied to compare the changes. Results: At the end of 12 weeks, compared with baseline, no statistically significant difference was observed in liver function tests (LFTs) and kidney function tests (KFTs) in the subjects. Conclusion: The findings clearly indicate that Vyoshadi Guggulu and Haritaki Churna are clinically safe and tolerable in subjects with obesity and dyslipidemia belonging to different age groups, gender, geographical area, and different Prakrti.

Clinical Efficacy and Safety of Navayasa Churna in the Management of Iron Deficiency Anemia

Introduction: Iron deficiency anemia (IDA) is a condition where deficiency of iron in the body leads to reduction in the number of red blood cells (RBC). Even though IDA is an easily manageable condition with excellent outcome, it is observed that modern iron preparation often irritates gastric mucosa and causes adverse effects. In Ayurveda, IDA can be correlated with pandu based on symptomatic similarity. Navayasa Churna is an iron containing herbomineral preparation used for the management of Pandu. In this study, clinical efficacy and safety of Navayasa Churna has been evaluated in IDA. Aims and objectives: To evaluate clinical efficacy and safety of Navayasa Churna in IDA. Materials and methods: An open-labeled multicenter prospective clinical trial was conducted at Ayurveda Regional Research Institute, Mandi; M.S. Regional Ayurveda Central Research Institute, Jaipur; and the National Institute of Ayurvedic Pharmaceutical Research, Patiala. Patients with IDA (n = 150) belonging to either sex, with hemoglobin in the range of 8 to 10%, aged between 18 and 50 years and with serum ferritin <30 mg/dL, and blood smear depicting microcytic, hypochromic state were selected. Navayasa Churna was given 1 gm (2 capsules of 500 mg each) twice daily with water for 90 days with a follow-up period of 1 month without drug. Assessment was done based on the relief in clinical symptoms of IDA and hematological parameters. Safety assessment was done through analysis RESEARCH ARTICLE 1,3,4,6,8,11-13Research Officer (Ayurveda), 9Statistical Officer (Statistics), 2,5,7,14Assistant Director (Ayurveda), 10Senior Statistical Assistant (Statistics), 15Deputy Director General (Ayurveda) 1Ministry of AYUSH, New Delhi, India 2,5Regional Ayurveda Research Institute for Nutritional Disorders, Mandi, Himachal Pradesh, India 4,7,9-15Central Council for Research in Ayurvedic Sciences, New Delhi, India 3Central Ayurveda Research Institute for Respiratory Disorders Patiala, Punjab, India 6M.S. Regional Ayurveda Research Institute for Nutritional Disorders, Jaipur, Rajasthan, India 8Central Ayurveda Research Institute for Hepatobiliary Disorders, Bhubaneshwar, Odisha, India Corresponding Author: Babita Yadav, Research Officer (Ayurveda), Central Council for Research in Ayurvedic Sciences, New Delhi, India, Phone: +911128080453, e-mail: drbabitayadav@gmail.com of liver function tests (LFTs) and kidney function tests (KFTs) before and after the trial period. Results: The formulation showed significant relief in cardinal symptoms of anemia and also in hemoglobin level. No adverse events/effects were was noted during trial period. The values of LFT and KFT were observed to be within limits during the entire period. Conclusion: Navayasa Churna in the above-mentioned dose and duration was found effective and safe in patients suffering from IDA.

Clinical Efficacy and Safety of “Vasavaleha” in the Management of Stable Chronic Bronchitis: A Prospective Open Label Multicenter Study

Introduction: Chronic bronchitis is one of the common clinical problems seen in middle–older age group and occurs as a result of inflammation and swelling of the lining of the airways, leading to narrowing and obstruction generally resulting in persistent cough, associated with wheezing, chest pain, and shortness of breath. Chronic bronchitis can be symptomatically compared with Kasa Roga in Ayurveda. Aims and objectives: To evaluate the efficacy and safety of Vasavaleha in patients suffering from stable chronic bronchitis (CB). Materials and methods: A prospective, open label multicenter study was carried out at three peripheral units under intramural clinical research program from 2012 to 2013. One hundred and twenty six patients satisfying the selection criteria were enrolled at the Outpatient Department of the centers and were administered Vasavaleha (10 gm) twice daily after food with water for 12 weeks. Follow-up was done finally after 2 weeks without medication. Laboratory parameters were assessed at baseline, 42nd day, and at the end of the treatment period of 12 weeks (i.e., 84th day). Paired sample t-test was used to compare mean change from baseline to the 84th day. A p-value of <0.05 was considered significant. Results: At the end of 12 weeks, statistically significant improvement was observed in clinical symptoms of CB and also in peak expiratory flow rates (PEFR), forced expiratory volume (FEV1), and St. George Respiratory Questionnaire (SRGQ) Score (p < 0.001). The treatment was found to be safe and effective in the patients of CB as all the safety parameters were RESEARCH ARTICLE 1,3Assistant Director (Ayurveda), 2,4,6-10Research Officer (Ayurveda), 5Research Officer (Research), 11Statistical Officer (Ayurveda), 12Director General (Ayurveda) 1,6Regional Ayurveda Research Institute for Mother and Child Health, Nagpur, Maharashtra, India 2,7M.S. Regional Ayurveda Research Institute for Endocrine Disorders, Jaipur, Rajasthan, India 3,8Regional Ayurveda Research Institute for Skin Disorders Vijayawada, Andhra Pradesh, India 4,5,9-12Central Council for Research in Ayurvedic Sciences, New Delhi, India Corresponding Author: Babita Yadav, Research Officer (Ayurveda), Central Council for Research in Ayurvedic Sciences, New Delhi, India, Phone: +911128080453, e-mail: drbabitayadav@gmail.com within the normal range. No adverse drug reaction or adverse event was reported during the trial period. Conclusion: Vasavaleha in the above prescribed dose is found to be effective and safe in the management of stable CB.

Clinical Safety of Selected Ayurvedic Formulations in Iron Deficiency Anemia

Introduction: Anemia is a condition in which the number of red blood cells (RBCs) or their oxygen-carrying capacity is insufficient to meet physiologic needs of the body and is characterized by a constellation of symptoms. Ayurveda compares the symptoms of anemia with that of the disease Pandu. Punarnavadi Mandura, Dadimadi Ghrta, Navayasa Churna, and Dhatri Lauha are few among the multitudes of medicines that are currently prevalent in use for the management of Pandu. However, the safety of these drugs were not evaluated until now through clinical drug trials. Objective: Critical analysis and presentation of clinical safety and efficacy outcomes of classical Ayurvedic formulations, viz., Dhatri Lauha, Navayasa Churna, Punarnavadi Mandura, and Dadimadi Ghrta in iron deficiency anemia (IDA). Materials and methods: A retrospective analysis of data collected from three different clinical studies that had been completed in peripheral institutes of Central Council for Research in Ayurvedic Sciences (CCRAS) were critically evaluated to assay the safety profile of four drugs, namely Dhatri Lauha, Navayasa Churna, Punarnavadi Mandura, and Dadimadi Ghrta in patients of IDA. Safety assessments were done through analyzing liver function test (LFT) and renal function test before and after the trial period. Paired sample t-test was used to compare the mean changes from baseline to the end of the trial period. A p-value of <0.05 was considered significant. Drug compliance and adverse drug reaction (ADR)/adverse events (AE), if any, were noted. RESEARCH ARTICLE 1,3,4,6,7,9-13,15Research Officer (Ayurveda), 2,8,17Assistant Director (Ayurveda), 5Former Assistant Director (Ayurveda), 14Statistical Officer (Statistics), 16Senior Statistical Assistant (Statistics) 18Deputy Director General (Ayurveda) 1,2,10,13-18Central Council for Research in Ayurvedic Sciences New Delhi, India 3,12Central Ayurveda Research Institute for Hepatobiliary Disorders, Bhubaneshwar, Odisha, India 4,9M.S. Regional Ayurveda Research Institute for Endocrine Disorders, Jaipur, Rajasthan, India 5,8Regional Ayurveda Research Institute for Nutritional Disorders Mandi, Himachal Pradesh, India 6Central Ayurveda Research Institute for Respiratory Disorders Patiala, Punjab, India 7,11Ministry of Ayush, New Delhi, India Corresponding Author: Babita Yadav, Research Officer (Ayurveda), Central Council for Research in Ayurvedic Sciences, New Delhi, India, Phone: +911128080453, e-mail: drbabitayadav@gmail.com Conclusion: The findings in the three different clinical studies clearly reveal that Punarnavadi Mandura, Navayasa Churna, Dhatri Lauha, and Dadimadi Ghrta are clinically safe, effective, and tolerable.

Clinical Efficacy and Safety of Mahatriphaladya Ghrita in the Management of Allergic Conjunctivitis: A Prospective Open Label Multicenter Study.

Introduction: Allergic conjunctivitis is a mild, nonspecific inflammation of the conjunctiva due to allergy with symptoms of conjunctival congestion, mild papillary response, and intense itching without any known specific condition for pathology to develop or with undetermined etiology that is mostly and easily attributed to allergy. Aims and objectives: To evaluate the efficacy and safety of Mahatriphaladya Ghrita and Triphala Kwath (Aschyotana) in patients suffering from allergic conjunctivitis. Materials and methods: A prospective, open label multicenter study was carried out at two peripheral centers of the Central Council for Research in Ayurvedic Sciences (CCRAS). Totally, 54 patients satisfying the selection criteria were enrolled from the outpatient department (OPD) of these centers and were administered Mahatriphaladya Ghrita (15 mL) twice daily on an empty stomach in the morning and 3 hours before meals in the evening with lukewarm water for 12 weeks and Triphala Kvatha (10 drops) Aschyotana twice daily for 12 weeks. All the participants were subjected to complete physical and ophthalmic examination along with blood investigations. Follow-up was done finally after 2 weeks without medication. Laboratory parameters, viz., absolute eosinophil count (AEC), liver function tests, kidney function tests, lipid profile, total leukocyte count (TLC) were assessed at baseline and at the end of the treatment period of 12 weeks (i.e., 84th day). Paired sample t-test was used to compare mean change from baseline to the 84th day on the outcome variables assessed by visual analog scale (VAS, 0–100 mm) and on the laboratory examination. A p-value of <0.05 was considered significant. Results: At the end of 12 weeks, compared with baseline, statistically significant improvement was observed in symptoms, viz., redness, anxiety, lacrimation, photophobia, burning, and ReSeARch ARticle 1-6,9Research Officer (Ayurveda), 7Statistical Officer, 8Statistical Assistant, 10Director 11Deputy Director General, 12Director General 1,3Regional Ayurveda Research Institute for Eye Diseases Lucknow, Uttar Pradesh, India 2,10Central Ayurveda Research Institute for Cardiovascular Diseases, New Delhi, India 4-9,11,12Central Council for Research in Ayurvedic Sciences New Delhi, India Corresponding Author: Shruti Khanduri, Research Officer (Ayurveda), Central Council for Research in Ayurvedic Sciences New Delhi, India, e-mail: drshruticcras@gamil.com foreign body sensation (p < 0.001). The treatment was found to be safe and effective in the subjects of allergic conjunctivitis as all the safety parameters were within the stipulated range. No adverse drug reactions or adverse events were reported during the trial period. Conclusion: Mahatriphaladya Ghrita and Triphala Kwath (Aschyotana) administered in the above-mentioned dose were found effective and safe in patients suffering from allergic conjunctivitis.

Clinical Safety of Selected Ayurvedic Formulations in Common Eye Diseases

Introduction: Allergic conjunctivitis (AC), dry eye syndrome (DES), and computer vision syndrome (CVS) are few of the eye diseases that commonly affect the working class. Allergic conjunctivitis is often associated with Kaphaja abhishyanda. Dry eye syndrome is caused due to chronic lack of sufficient lubrication and moisture on the surface of the eye. The CVS is a visual complaint that is clinically similar to DES. In Ayurveda, the symptoms of DES can be included under the spectrum of two different diseases, Krichronmeela and suskakshipaka. Tarpana, Aschyotana, Nasya, and oral use of Ayurvedic medicines are commonly advocated for eye diseases. Objective: Critical analysis and presentation of clinical safety and efficacy outcomes of classical Ayurvedic formulations, viz., Mahatriphaladya ghrita, Triphala kwatha, and Anu taila, in patients of common eye diseases. Materials and methods: Data were collected from three different clinical studies, viz., AC, DES, and CVS, that have been completed in peripheral institutes of Central Council for Research in Ayurvedic Sciences (CCRAS) and were critically evaluated to assay the safety profile of three drugs. Clinical safety assessments were done through analyzing liver function tests (LFTs) and kidney function tests (KFTs) before and after the trial period. Paired sample t-test was used to compare the mean changes from baseline to the end of the trial period. The study revealed that all the parameters were within the specified limits during the entire period. Conclusion: The findings in the three different clinical studies clearly reveal that Mahatriphaladya ghrita, Triphala kwath, and Anu taila are clinically safe, effective, and tolerable in common eye diseases.