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Clinical Trials/CTRI/2017/11/010409
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.

Registry
who.int
Start Date
TBD
End Date
December 17, 2016
Last Updated
4 years ago
Study Type
Interventional

Investigators

Sponsor
Interactive Research school for health Affairs

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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