CTRI/2023/08/056950
Not yet recruiting
Phase 2
Development, standardization, and clinical evaluation of Ayurvedic therapeutic food made from Amaranthus and Ragi for sthaulya (obesity) - NI
Mr Manoj Khanna cofounder0 sites0 target enrollmentTBD
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Mr Manoj Khanna cofounder
- Status
- Not yet recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\) Patients of age range between 20\-60 years
- •2\) Patients having BMI equal to or more than 27\.5 kg/ m 2 (obese).
- •3\) Patients having at least 4 of 9 selected clinical signs and symptoms of sthaulya. (refer annexure II)
- •4\) Patients who are willing to follow diet as well as exercise.
Exclusion Criteria
- •1\) Patient who have attempted weight loss 3 months prior to enrolling in this study.
- •2\) Pregnant woman and lactating mothers
- •2\) Known case of diabetes, known hypertension, cardiovascular diseases, know case of PCOD
- •3\) Patients suffering from any psychiatric disorder
- •4\) Obesity due to known hormonal imbalance like thyroid.
Outcomes
Primary Outcomes
Not specified
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Kunnen kinderen (niet) goed beslissen over meedoen aan medicatieonderzoek?children's competence to consent, informed consent in minors, children's consent in drug trials.wilsbekwaamheid bij kinderen, informed consent bij minderjarigen, informed consent bij kinderen in medicatieonderzoek.NL-OMON27426Academic Medical Center Amsterdam and de Bascule Amsterdam160