Safety and efficacy study of Triphala and Trimad in obseity

Not Applicable

Completed

• Registration Number: CTRI/2017/11/010409
• Lead Sponsor: Interactive Research school for health Affairs

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2016-12-17
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 120

Inclusion Criteria

1.Obesity (BMI >=30.0 kg/m2); or overweight (BMI >=25.0 kg/m2) with controlled co-morbid dyslipidemia and/or hypertension and/or type 1 or type 2 diabetes

2.Stable body weight (less than 5 kg self-reported change during the previous 3 months)

3.Age >=18 years to <=60 years

4.Willing to give Informed consent before any trial-related activity takes place

Exclusion Criteria

1.Known case of any other endocrinological disorders

2.Current or history of treatment with medications that may cause significant weight gain, within 3 months prior to screening, including

oAllopathic medicines: systemic corticosteroids (except for a short course of treatment, i.e. 7â??10 days),tri-cyclic antidepressants, atypical antipsychotic and mood stabilizers (e.g. imipramine, amitriptyline, mirtazapine, paroxetine, phenelzine, chlorpromazine, thioridazine, clozapine, olanzapine, valproic acid and its derivatives, and lithium)

oAyurvedic medicines: Shatavari, Ashwagandha, Bala etc.

3.History of use/ currently using dietary supplements, over-the-counter medications or below mentioned Allopathic /Ayurvedic medicines one month before screening

oAllopathic medicines: pramlintide, sibutramine, orlistat, zonisamide, topiramate, phentermine, or metformin (either by prescription or as part of a clinical trial)

oAyurvedic medicines: Guggulu, Trikatu, Triphala, Trimada, Shilajatu and/ or any other ayurvedic medicine (causing weight reduction) either individually or as a part of any other formulation

4.Current participation (past one month) in an organized weight reduction program

5.Participants with a history of major depressive or other severe psychiatric disorders or an eating disorder

6.Surgery scheduled for the trial duration period, except for minor surgical procedures, at the discretion of the investigator

7.Females of child-bearing potential who are pregnant, breast-feeding or intend to become pregnant or are not using adequate contraceptive methods

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
weight lossTimepoint: every fifteen day from day of recruitment

Secondary Outcome Measures

Name	Time	Method
body fat monitor parameters, inches lossTimepoint: every fifteen day from day of recruitment