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Clinical study of Nisha Amalaki extract in Prediabetic with special reference to Prameha.

An open randomised control clinical study of Nisha Amalaki extract in Prediabetic with special reference to Prameha.

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2023/11/060110
Enrollment
124
Registered
2023-11-22
Start date
Unknown
Completion date
Unknown
Last updated
2023-12-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: E70-E88- Metabolic disorders Health Condition 2: E119- Type 2 diabetes mellitus without complications

Interventions

None listed

Sponsors

DR SAJIDA D ATTAR
Lead Sponsor

Eligibility

Inclusion criteria

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

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 5.Subjects with known Chronic Infectious Disease, such as active Tuberculosis, Hepatitis B or C, or HIV. 6.Pregnant female and lactating mother

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
To compare mode of action of nisha amalaki extract & tab metformin in management of prediabetis 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

Countries

India

Contacts

Public ContactDR SAJIDA D ATTAR

APMS AYURVED MAHAVIDYALAYA SION

hemant.paradkar@gmail.com9987519315

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026