Clinical study of Nisha Amalaki extract in Prediabetic with special reference to Prameha.
Phase 4
- Conditions
- Health Condition 1: E70-E88- Metabolic disordersHealth Condition 2: E119- Type 2 diabetes mellitus without complications
- Registration Number
- CTRI/2023/11/060110
- Lead Sponsor
- DR SAJIDA D ATTAR
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
1)Having IDRS score more than 50.
2)HbA1c level of 5.7-6.4%
3)A fasting blood Sugar level (FBS) of 110-125 mg/dL ; (fasting is done as no caloric intake for at least 8 hours.)
4)A 2-hour Blood Sugar level (PPBS) of 140 to 199 mg/dL .
Exclusion Criteria
1.Exclusion criteria included people currently using oral hypoglycemic agents (OHAs); those reporting prior use of medication to treat diabetes mellitus.
2.Type ll Diabetes Mellitus (NIDDM)
3.Type l Diabetes Mellitus (IDDM)
4.Subjects giving history of signicant cardiovascular event < 12 weeks prior to study
5.Subjects with known Chronic Infectious Disease, such as active Tuberculosis, Hepatitis B or C, or HIV.
6.Pregnant female and lactating mother
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To evaluate efficacy of Nisha Amalaki extract on symptoms of prediabetic as per subjective and objective assessment mentioned in synopsisTimepoint: at every follow up 15th day, 30th day, 45th day, 60th day, 75 th day, 90th day
- Secondary Outcome Measures
Name Time Method To compare mode of action of nisha amalaki extract & tab metformin in management of prediabetis <br/ ><br>to check safety or adverse effect of the drugsTimepoint: at every follow up 15th day, 30th day, 45th day, 60th day, 75 th day, 90th day