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Study comparing the effect of Nishamalaki Churna with standard diabetes treatment versus standard treatment alone in patients with Type 2 diabetes.

A Comparative Study on the Efficacy of Nishamalaki Churna Combined with Allopathic Therapy Versus Allopathic Therapy Alone in the Management of Type 2 Diabetes Mellitus - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2026/05/110829
Enrollment
70
Registered
2026-05-21
Start date
Unknown
Completion date
Unknown
Last updated
2026-06-01

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

Conditions

Health Condition 1: E118- Type 2 diabetes mellitus with unspecified complications

Interventions

None listed

Sponsors

Datta Meghe Medical College, Wanadongri
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Participants willing and able to provide written informed consent prior to participation in the study. Male or female participants aged between 30 and 65 years. Diagnosed with Type 2 Diabetes Mellitus (T2DM) for at least 1 year prior to screening. HbA1c between 7.0% and 10.5% at the time of screening. Stable body weight, defined as no more than 5 kg change during the 3 months prior to screening. Receiving a stable dose of oral antidiabetic therapy for at least 3 months prior to screening. Participants willing and able to comply with study procedures and follow-up visits.

Exclusion criteria

Exclusion criteria: Insulin therapy Known allergy to any component of Nishamalaki Churna Liver failure Kidney failure Pregnant or lactating women Use of other Ayurvedic or herbal products Any history of major illness or surgical procedure in the last three months BMI less than 18 or more than or equal to 40 History of weight loss medications in the last 6 months

Design outcomes

Primary

MeasureTime frame
Change in Fasting Plasma Glucose (mg/dL) from baseline to 12 weeks of intervention. Change in Postprandial Blood Glucose (mg/dL) from baseline to 12 weeks of intervention. Change in Glycated Hemoglobin (HbA1c %) from baseline to 12 weeks.Timepoint: 2 weeks 6 weeks 8 weeks 12 weeks—

Secondary

MeasureTime frame
Change in lipid profile (Total Cholesterol, LDL, HDL, Triglycerides) from baseline to 12 weeks. Change in body weight (kg) from baseline to 12 weeks. Change in Body Mass Index (BMI kg/m ) from baseline to 12 weeks. Safety and tolerability assessment, including: Complete Blood Count (CBC) Liver Function Tests (LFT) Renal Function Tests (RFT) Monitoring of adverse drug reactions or herb drug interactions assessed from baseline to 12 weeks.Timepoint: 12 weeks—

Countries

India

Contacts

Public ContactDr Chinmay Khotele

Datta Meghe Medical College Nagpur

gosavirv.smhrc@gmail.com9890225111

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Jun 11, 2026