None listed
Conditions
Interventions
Intervention1: Triphala, Trimad and Placebo: triphala, trimad and placebo (randomly)
Overweight (BMI â?¥ 25kg/m2)â??2 tablets (500mg each) two times in a day
Obese (BMI â?¥ 30kg/m2)â??2 tablets (500
Sponsors
Interactive Research school for health Affairs
Eligibility
Inclusion 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 4. Willing to give Informed consent before any trial-related activity takes place
Exclusion criteria
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 o Allopathic 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) o Ayurvedic 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 o Allopathic medicines: pramlintide, sibutramine, orlistat, zonisamide, topiramate, phentermine, or metformin (either by prescription or as part of a clinical trial) o Ayurvedic 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| weight lossTimepoint: every fifteen day from day of recruitment | — |
Secondary
| Measure | Time frame |
|---|---|
| body fat monitor parameters, inches lossTimepoint: every fifteen day from day of recruitment | — |
Countries
India
Contacts
Public ContactDr Supriya Bhalerao
Interactive Research School for Health Affairs (IRSHA)
Outcome results
None listed