CTRI/2018/08/015503
Not yet recruiting
Phase 4
A Single-blind, Randomized, Controlled, Phase IV, Proof-of-Concept, comparative study to evaluate the efficacy and safety of Nisha-Amalki capsules in preventing progression to Diabetes in patients with Pre-Diabetes - Efficacy of Nisha Amalki in Pre-diabetics - RCT
Overview
- Phase
- Phase 4
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- PHARMANZA HERBAL PVT LTD
- Status
- Not yet recruiting
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Individuals fulfilling one or more laboratory criteria\- Fasting blood sugar between 100\-125 mg/dl, 2 hours glucose value between 140\-199 mg/dl, IDRS (Indian Diabetics Risk score) less than or equal to 60\.
- •2\. Those ready to give written informed consent.
Exclusion Criteria
- •1\.Individuals with history of smoking, alcohol or tobacco addiction
- •2\.Those with history of any major illness like hypertension, renal disorders, tuberculosis, epilepsy, neuropathies and psychiatric disorders.
- •3\.Pregnant and lactating women.
- •4\.Those who refused consent to participate in study.
Outcomes
Primary Outcomes
Not specified
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