CTRI/2017/11/010409
Completed
未知
Evaluation of the safety and efficacy of Triphala and Trimad in Obese and overweight individuals: A pilot clinical study
Interactive Research school for health Affairs0 sites120 target enrollmentTBD
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Interactive Research school for health Affairs
- Enrollment
- 120
- Status
- Completed
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
Not specified
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