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A clinical trial to study the effects of two drugs, herbal medicine(nisha-aamalaki yoga) and coarse wheat powder (placebo) in patients with initial condition of diabetes mellitus (pre-diabetes)

A Double Blind, Randomized, Placebo Controlled Evaluation on the Effect of Nisha Aamalaki Yoga in Pre-diabetes.

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2020/03/023935
Enrollment
160
Registered
2020-03-13
Start date
Unknown
Completion date
Unknown
Last updated
2025-06-24

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

Conditions

Health Condition 1: E110- Type 2 diabetes mellitus with hyperosmolarity

Interventions

Intervention1: Nisha-Aamalaki Yoga: Nisha-Aamalaki Yoga 1gm twice in a day with ushnodaka before food for 3 months Control Intervention1: Placebo (roasted wheat powder): Placebo (roasted wheat powder)

Sponsors

Parul University
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1) Patients fulfilling the criteria of diagnosis according to American Diabetes Association7. 2) Patients of either sex between age group of 20 to 70 years (both years inclusive). 3) Patient willing to sign informed consent and able to participate in the study procedure.

Exclusion criteria

Exclusion criteria: 1) Patients having Diabetes mellitus, insulin dependent diabetes mellitus, juvenile diabetes mellitus and Gestational diabetes mellitus. 2) Patients having major systemic diseases like IHD, malignancies, uncontrolled hypertension etc. 3) Immunocompressive patients-HIV. 4) Patients with infective diseases- active tuberculosis, Hepatitis B. 4) Patients on prolonged medication ( >6weeks) with corticosteroids, or any other drugs that may have an influence on the outcome of the study. 5) Pregnant and lactating women. 6) Patients who are currently participating in any other clinical trials (since last 2 months).

Design outcomes

Primary

MeasureTime frame
Primary outcome will be conversion of pre-diabetic condition to non-diabetic condition within 3 monthsTimepoint: 3 months

Secondary

MeasureTime frame
Secondary outcome will be delaying in conversion of pre-diabetic condition to diabetic condition and other lifestyle disorders.Timepoint: 6 months

Countries

India

Contacts

Public ContactNisha Jagannath Munishwar

Parul University

dr.shaileshd@gmail.com9763104451

Outcome results

None listed

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