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A Comparative Study to evaluate the efficacy of Patha Vidanga Arjuna Dhanvana Kwath with conventional medicine alone in control of “Metabolic Syndrome"

Phase 2/3
Completed
Conditions
Other specified metabolic disorders. Ayurveda Condition: PRAMEHAH,
Registration Number
CTRI/2022/04/042194
Lead Sponsor
Dhanwantarikumar Harinath Jha
Brief Summary

The Metabolic Syndrome is a cluster of factors, namely central obesity, glucose intolerance, low amount of High-density lipoprotein (HDL), high triglycerides (TG) and systemic hypertension. It has a high prevalence rate with more than 10 million cases per year In India. In India, recent rise in Metabolic Syndrome has been attributed to the shift in lifestyles, both in the urban and in the rural areas. Metabolic Syndrome has the potential to double the risk of cardiovascular diseases, which is one of the major leading causes of adult death. Metabloic syndrome usually requires a team work of Endocrinologists, Cardologists and Nutritionists. Ayurveda being a Holistic system of Medicine can single handedly handle this complex condition with its Dosha based treatment system. And moreover it directly falls under the category of Sthula Pramehi (Obese Diabetic) which is clearly and elaborately mentioned in our texts along with its management. Thus, Ayurveda already has what it takes to manage Metabolic Syndrome well and that too without inducing any adverse effects of drugs. The Prameha chapter of Chikitsa sthan of Charak Samhita mentions many formulations for the management of different types of Prameha’s. For the management of Kaphaj Prameha there is a mention of 10 kwath formulations: हयीतकीकटà¥à¤ªà¤°à¤­à¥à¤¸à¥à¤¤à¤°à¥‹à¤§à¥à¤°à¤‚ ऩाठाविडङà¥à¤—ारà¥à¥à¥à¤¨à¤§à¤¨à¥à¤¿à¤¨à¤¾à¤¶à¥à¤š| उबे हरयदà¥à¤°à¥‡ तगयं विडङà¥à¤—ं कदमà¥à¤«à¤¶à¤¾à¤°à¤¾à¤°à¥à¥à¥à¤¨à¤¦à¥€à¤ªà¥à¤®à¤•ाशà¥à¤š||२७|| दािी विडङà¥à¤—ं खददयो धिशà¥à¤š सà¥à¤¯à¤¾à¤¹à¥à¤µà¤•à¥ô€†µà¤¾à¤—à¥à¤°à¥à¤šà¤¨à¥à¤¦à¤¨à¤¾à¤¨à¤¨| दारà¥à¤µà¤®à¥à¤—à¥à¤¨à¤¨à¤­à¤¨à¥à¤¥à¥Œ विपरा सऩाठा ऩाठा च भूिाॠच तथा शà¥à¤µà¤¦à¤‚षà¥à¤Ÿà¤¾||२८|| मिानà¥à¤®à¥à¤¶à¥€à¤¯à¤¾à¤£à¥à¤®à¤¬à¤®à¤¾à¤—à¥à¤¡à¥‚चीचरà¥à¤µà¤®à¤¾à¤¬à¤®à¤¾à¤¨à¤šà¤¿à¤•सपà¥à¤¤à¤©à¤°à¤¾à¥à¥| ऩाद ॠकषामाॠकपभेदहनां ते दशोऩददô€†´à¤¾ भधà¥à¤¸à¤®à¥à¤°à¤®à¥à¤•à¥à¤¾à¥||२९|| We will use one of these formulations, which has a combination of Patha (Cissampelos pareira), Vidang (Embelia ribes), Arjuna (Terminalia arjuna) and Dhanvana (Grewia tiliaefolia) for our research.

Detailed Description

Not available

Recruitment & Eligibility

Status
Completed
Sex
All
Target Recruitment
140
Inclusion Criteria
  • o Age 40-65 Yrs.
  • o Patients with Metabolic syndrome according to NCEP ATP3 Criteria.
Exclusion Criteria
    1. Age <40yrs.
    1. With associated heart disease or other secondary complications.

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Fasting plasma glucose ≥ 6.1 mmol/L (110 mg/dl)At the end of 30 days, 60 days and 90 Days.
Reduction in following criteria which are base for diagnosis of Metabolic Disorder:At the end of 30 days, 60 days and 90 Days.
Blood pressure ≥ 130/85 mmHg (or treated for hypertension)At the end of 30 days, 60 days and 90 Days.
Central obesity: Waist circumference ≥ 102 cm or 40 inches (male), ≥ 88 cm or 35 inches(female)At the end of 30 days, 60 days and 90 Days.
TG ≥ 1.7 mmol/L (150 mg/dl)At the end of 30 days, 60 days and 90 Days.
HDL-C 40 mg/dL (male), 50 mg/dL (female)At the end of 30 days, 60 days and 90 Days.
Secondary Outcome Measures
NameTimeMethod
Improvement in Quality of life:Based on the signs & symptoms reported by the patients before and after treatment, relief in mental & physical health will be accessed on the basis of grading developed for these clinical factors and it will be followed by statistical analysis.

Trial Locations

Locations (1)

Dr. D. Y. Patil Ayurved Hospital, Pimpri, Pune

🇮🇳

Pune, MAHARASHTRA, India

Dr. D. Y. Patil Ayurved Hospital, Pimpri, Pune
🇮🇳Pune, MAHARASHTRA, India
Dr Dhanwantarikumar Harinath Jha
Principal investigator
9998270582
dhanwantari4u@gmail.com

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