A Clinical Trial To Study The Effect Of Ayurvedic Medication On Sthoulya (obesity)

Phase 2

Not yet recruiting

• Conditions: Overweight,

• Registration Number: CTRI/2020/09/027508
• Lead Sponsor: National Institute of Ayurveda

Brief Summary

The objectives of this prospective cohort study (provisional sample size 200 urban patients) are (a) Generation of cross sectional data on Prakriti, body composition, presence of adipocytokines flux / hematologic markers in peripheral blood, ectopic lipid deposition, insulin resistance and clinical/biochemical parameters of diabetes, hypertension, dyslipidemia and atherosclerotic vascular disease in members of Jaipur families at high risk of T2DM. (b) application of data so generated in development of a staging system of Medoroga - dysmetabolism (adiposopathy/sick fat, allopath equivalent of *Medo Roga*), (c)  study effect of Nyagrodhadi Ghana vati and Medohara guggulu on Medoroga -dysmetabolism (parameters of adiposopathy).

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2020-08-18
• Study Start: 2020-09-20

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

• Subjects with LDL-C ≥ 130(mg/dl) at the time of screening.
• Subjects with BMI ≥24 3.
• Subjects willing to follow the procedures as per the study protocol and voluntarily give written informed consent.

Exclusion Criteria

• Subjects with Diabetes Mellitus Type I and uncontrolled Diabetes Mellitus Type II.
• Subjects with uncontrolled Hypothyroidism or Hyperthyroidism 3.
• Known cases of Severe/Chronic Hepatic or Renal disease 4.
• Known subject of any active malignancy.
• Subjects giving history of significant cardiovascular event < 12 weeks prior to randomization.
• Known case of Anorexia Nervosa or Bulimia nervosa 7.
• Chronic alcoholics / Alcohol Abuse 8.
• Subjects ECG demonstrating any signs of uncontrolled arrhythmia / acute ischemia.
• Subjects X- ray chest showing any active lesion of tuberculosis 10.
• Subjects having known chronic, contagious infectious disease, such as active tuberculosis Hepatitis B or C, or HIV.
• Subjects using any other investigational drug within 1 month prior to recruitment 12.
• Known hypersensitivity to any of the ingredients used in study drug 13.
• Pregnant and Lactating females.
• Subjects currently participating in any other Clinical study 16.
• Any other medical or surgical condition considered unsuitable for subject participation in the study as per Investigator’s judgment.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1.Change in LDL-C level at the end of study	Baseline, 6th Week, 12th Week
2.Change in body weight at the end of study	Baseline, 6th Week, 12th Week

Secondary Outcome Measures

Name	Time	Method
1.Change in LDL-C level at 6 weeks	2.Change in other lipid parameters such as Triglycerides (TG), Total Cholesterol (TC) and High Density Lipoprotein (HDL) at 6 weeks and 12 weeks.

Trial Locations

Locations (1)

National institute of Ayurveda; 🇮🇳 Jaipur, RAJASTHAN, India

National institute of Ayurveda

🇮🇳Jaipur, RAJASTHAN, India

BHAGYA RANJAN DASH

Principal investigator

7018229414

drbhagyaranjan86@gmail.com