A clinical study to evaluate the efficacy and safety of Nisha-Amalki capsules in preventing progression to Diabetes in patients with Pre-Diabetes

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

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2018/08/015503

Enrollment

Registered

2018-08-28

Start date

Unknown

Completion date

Unknown

Last updated

2026-02-02

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

Conditions

None listed

Interventions

Intervention1: Nisha-Amalaki Capsule: In dose of 1 capsule (500 mg) twice a day along with specific diet and exercise for 6 months Control Intervention1: Placebo: In dose of 1 capsule (500 mg) twice a

Eligibility

Inclusion 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

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.

Design outcomes

Primary

Measure	Time frame
Change in 1.Body weight 2.BMI 3.Fasting and PP Blood Sugar 4.OGTT 5.HbA1C 6.Sr. Insulin 7.Lipid profile 8.Oxidative stress markers (MDA & SOD) 9.C reactive protein for inflammationTimepoint: 0 days and 180 days	—

Secondary

Measure	Time frame
1.Ayurvedic symptom Score for pre-Diabetes 2.Health related quality of life (HRQOL)Timepoint: 0 Days and 180 days	—

Countries

India

Contacts

Public ContactDr Renuka Munshi

T N Medical College and BYL Nair Hospital

renuka.munshi@gmail.com02223014713

Outcome results