A controlled clinical study to evaluate the efficacy of Varadarvyadi Ghana Vati as an adjuvant drug to metformin in the management of Prameha with special reference to Type 2 Diabetes Mellitus
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- 1) To study the effect of in Varadarvyadi Ghanavati the symptoms of Prameha like Prabhutamutrata (Polyuria), Pipasavruddhi (Polydipsia), Kshudhavruddhi(Increased Hunger), Mutramadhurya (Glycosuria), Swedadhikya(Profuse sweating) at 4th week, 6th week, 8th week, 10th week and 12th week.
研究概览
简要总结
Ayurveda is an ancient system of medicine having roots in the Indian Subcontinent. The aim of Ayurveda is prevention of disease, prolongation of healthy life, to help a person to attain the four principle of life that is Dharma, Artha, Kama, Moksha. Ayurveda provides optimal health and wellbeing through a comprehensive approach that addresses mind, body, behavior and environment.
Prameha is described as one of the Ashtamahagada in ayurveda samhita. Prameha which has been a global problem is described in ancient Indian classics like Charak Samhita, Sushruta Samhita, Ashtanga Sangraha, Ashtanga Hridaya, Yogratnakara etc. It’s described thoroughly as etiology, pathogenesis, prognosis, complications, it’s management. The Indian ancient samhitas also describe the relationship of dietary, lifestyle, environment and genetic factors. The Prameha which was described as mahagada in ancient time is still difficult to treat in 21st century.
The pathogenesis of Prameha indicates that vitiated Three Doshas (vata, pitta, kapha) and Ten Dushyas (rasa, rakta, mansa, meda, majja, shukra, lasika, vasa and ooj) are responsible for development of Prameha according to Ayurveda. The main dosha is vitiated kapha dosha is responsible in the samprapti of Prameha (kaphakrut ch sarvam). Acharya described 20 types of Prameha on the basis of predominance of dosha and appearance of mutra(urine).
In this era of globalization, lifestyle is changing everyday. The living habits, eating habits of people are changing day to day. Irregular food intake, lack of exercise, excessive stress, work life imbalance, disturbed sleep pattern eventually affect the metabolism of human body. These give rise to lifestyle disorders. Diabetes is characterised by hyperglycemia i.e. raised blood glucose level developing the symptoms like polydipsia, polyphagia, polyuria, nocturia, Fatigue etc. The prevalence of diabetes in India in adults is estimated to be 11.3%.
Ayurveda samhitas have such wonderful formulations. The kalpa varadarvyadi ghanvati is described in sharangdhara samhita. The contents of this kalpa are 1)vara(triphala), 2)darvi(daruharidra), 3)musta, 4)deodaru.
This combination of drugs mentioned above helps in sampraptibhanga of prameha and is easy to available. Taking all this consideration the study is taken up entitled “A controlled clinical study to evaluate the efficacy of ‘Varadarvyadi Ghanavati’ in the management of Prameha with special reference to Type 2 Diabetes Mellitus.
Scope of study :-
Though we have the tremendous medicines, modern medicine shows limitations in the management of metabolic diseases. Hence we are moving towards ayurvedic approach.
In India, prevalence of diabetic population is high. Diabetes mellitus hampers cellular components of organ or entire system. Diabetes is going to be a major health issue due to its serious complications. In the management of DM with modern medical science, we have to face related complications like GI upset, nausea, diarrhea, lactic acidosis etc. Here, ayurveda provides as an adjuvant therapy to modern medicine. Thus, there is need of clinical research in getting a hold on this disease not only to achieve good glycemic control but also to treat the root cause.
Number of patients :-
Group A: Study group - 45 patients will be administered Varadarvyadi Ghanavati along with Metformin.
Group B: Control group - 45 patients will receive only Metformin.
Investigations :-
Blood CBC, ESR, BSL fasting and PP, Liver Function and Renal Function Test, Lipid Profile to exclude any Pathology.
Glycosylated Hemoglobin(HbA1C) test will be estimated before and after treatment.
Summary and Conclusion:
The work will be summarized to make final conclusions.
Observations of results will be concluded with statistical analysis under the heading ‘Conclusion’ with explanation at the end of whole research.
Expected outcomes:
? Changes in subjective by ’Varadarvyadi Ghanavati’ towards reduction in previous severity.
? Changes in Glycosylated Hemoglobin(HbA1C) by ’Varadarvyadi Ghanavati’ towards reduction of Fasting and Post Prandial Blood Sugar Level.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 20.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- All
入选标准
- •Subjects who are willing to give written informed consent.
- •Patients having signs & symptoms of Prameha like Prabhutmutrata (Polyuria), Pipasadhikya (Polydipsia), Kshudhaadhikya (increased meals), Mutramadhurya (Glycosuria), Swedadhikya (Profuse sweating).
- •Patients having BSL (F) =
- •250 mg/dl (PP) =
- •350 mg/dl
- •HbA1c level = 6.
- •The patient of hyperglycemia along with clinical symptoms.
排除标准
- •Patient taking or requiring OHA other than metformin
- •Patient having IDDM, Juvenile Diabetes Mellitus, Gestational Diabetes Mellitus, diabetes with complications, Ketoacidosis, Drug induced Diabetes like use of glucocorticoid, thiazide diuretic etc.
- •Pregnant & lactating women
- •Hepatitis B, Hepatitis C, AIDS, Tuberculosis, CA or any other immunocompressive disorder and major life threatening diseases.
- •Patient with IHD, Kidney disease, CVA (Hemiplegia)
- •Patient on immunosuppressive therapy, on antidepressant agents, patient with hypothyroidism or hyperthyroidism.
- •Mentally retarded, Psychologically unstable and non-cooperative patients.
结局指标
主要结局
1) To study the effect of in Varadarvyadi Ghanavati the symptoms of Prameha like Prabhutamutrata (Polyuria), Pipasavruddhi (Polydipsia), Kshudhavruddhi(Increased Hunger), Mutramadhurya (Glycosuria), Swedadhikya(Profuse sweating) at 4th week, 6th week, 8th week, 10th week and 12th week.
时间窗: 1) To study the effect of in‘Varadarvyadi Ghanavati’ the symptoms of Prameha like Prabhutamutrata (Polyuria), Pipasavruddhi (Polydipsia), Kshudhavruddhi(Increased Hunger), Mutramadhurya (Glycosuria), Swedadhikya(Profuse sweating) at the time of 2nd week, 4th week, 6th week, 8th week, 10th week and 12th week | 2) To reduce the risk of IHD, Obesity, Hyperlipidemia with the use of Varadarvyadi Ghanavati after 12th week. | 3) To study the effect of ‘Varadarvyadi Ghanavati’ on BSL, HbA1c after 12 weeks.
2) To reduce the risk of IHD, Obesity, Hyperlipidemia with the use of Varadarvyadi Ghanavati with 12 weeks of duration
时间窗: 1) To study the effect of in‘Varadarvyadi Ghanavati’ the symptoms of Prameha like Prabhutamutrata (Polyuria), Pipasavruddhi (Polydipsia), Kshudhavruddhi(Increased Hunger), Mutramadhurya (Glycosuria), Swedadhikya(Profuse sweating) at the time of 2nd week, 4th week, 6th week, 8th week, 10th week and 12th week | 2) To reduce the risk of IHD, Obesity, Hyperlipidemia with the use of Varadarvyadi Ghanavati after 12th week. | 3) To study the effect of ‘Varadarvyadi Ghanavati’ on BSL, HbA1c after 12 weeks.
3) To study the effect of ‘Varadarvyadi Ghanavati’ on BSL, HbA1c after 12 weeks.
时间窗: 1) To study the effect of in‘Varadarvyadi Ghanavati’ the symptoms of Prameha like Prabhutamutrata (Polyuria), Pipasavruddhi (Polydipsia), Kshudhavruddhi(Increased Hunger), Mutramadhurya (Glycosuria), Swedadhikya(Profuse sweating) at the time of 2nd week, 4th week, 6th week, 8th week, 10th week and 12th week | 2) To reduce the risk of IHD, Obesity, Hyperlipidemia with the use of Varadarvyadi Ghanavati after 12th week. | 3) To study the effect of ‘Varadarvyadi Ghanavati’ on BSL, HbA1c after 12 weeks.
次要结局
- 1) To review the Ayurvedic & Modern literature on Type 2 Diabetes Mellitus. 2) To correlate Prameha vyadhi and Type 2 Diabetes Mellitus. 3) To asses the possible mode of action of Varadarvyadi Ghanavati.(At 2nd, 4th, 6th, 8th, 10th and 12th week)
研究者
Dr Aditya Hemant Redij
R A PODAR AYURVED MEDICAL COLLEGE WORLI, MUMBAI