A CLINICAL TRIAL TO STUDY THE EFFECT OF TRYUSHANADI GUGGULU AND NAVAKA GUGGULU IN THE PATIENTS HAVING SIGN AND SYMPTOMS OF MEDOROGA (ADIPOSOPATHY)

Phase 2

Completed

• Conditions: Obesity, unspecified, (2) ICD-10 Condition: E668||Other obesity,

• Registration Number: CTRI/2018/10/016123
• Lead Sponsor: NATIONAL INSTITUTE OF AYURVEDA JAIPUR

Brief Summary

This is an Open label Randomised single centre trial comparing efficacy of ayurvedic drugs Tryushanadi Guggulu and Navaka Guggulu in the management of Medoroga (adiposopathy). Patient of both sexes between age 18 to 60 years of medoroga will be selected for relieving sign and symptoms. 60 clinically diagnosed and confirmed patients will be randomly divided into two groups for administration of trial drugs. In group I, 30 patients will be administered trial drug tryushanadi guggulu in the dose of 1 gm BD orally for 4 weeks.  In group II, 30 patients will be administered trial drug navaka guggulu in the dose of 1 gm BD orally for 4 weeks.All the patients registered for the clinical trial will be asked for any changes in their clinical manifestations and growing feeling of well being. Conclusion- to compare the efficacy of both the drugs.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-05-11
• Study Completion: 2019-03-18
• Last Update Posted: 2019-11-26

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• 1-SUBJECTS OF AGE 18.
• 60 YEARS. 2-SUBJECTS OF EITHER SEX. 3-SUBJECTS FOUND TO BE SUFFERING WITH MEDOROGA IN THE NIDANATMAKA STUDY ON THE BASIS OF PARAMETERS SUCH AS ADIPOSOPATHY & DYSLIPIDEMIA AS WELL AS THE AYURVEDIC PARAMETERS AND THEREAFTER CONSENTING TO PARTICIPATE IN THE DRUG TRIAL AND NOT FALLING IN THE EXCLUSION CRITERIA WILL BE INCLUDED.

Exclusion Criteria

• 1-Patients having diabetes mellitus, malignant hypertension and other malignant disorders.
• 2-Patient having Hypersensitivity, anorexia nervosa, history of Coronary artery disease, Congestive heart failure (CHF), arrhythmias, stroke, cardiac disorders, and those receiving Mono amino oxidase inhibitors (MAOIs ) etc.
• 3-Pregnant and lactating mothers.
• 4-Patients having any hormonal disturbances like hypothyroidism.
• 5-Patients not complying with the directions of the physician.
• 6-BMI > 40 kg/m2 7-Patient with major complications and in requirement of emergency treatment.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
patients of both sexes between age group 18 to 60 years of medoroga will be selected for relieving sign and symptoms	4 weeks.

Secondary Outcome Measures

Name	Time	Method
Asses the comparative efficacy between Tryushanadi Guggulu and Navaka Guggulu in case of medoroga.	4 weeks

Trial Locations

Locations (1)

NATIONAL INSTITUTE OF AYURVEDA JAIPUR; 🇮🇳 Jaipur, RAJASTHAN, India

NATIONAL INSTITUTE OF AYURVEDA JAIPUR

🇮🇳Jaipur, RAJASTHAN, India

DR BALENDRA SINGH

Principal investigator

7587184418

balobamsias@gmail.com