A Study to Analyze the Combined effect of Metformin and Madhumega chooranam in the Management of Type 2 Diabetes Mellitus

Analyzing the synergy of Siddha integrations and interactions (Metformin and Madhumega chooranam) in the management of Type 2 Diabetes Mellitus among Out Patients attending the OPD of Ayothidoss Pandithar Hospital, National Institute of Siddha-A Randomized Controlled Trial - NIL

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2024/06/069026

Enrollment

Registered

2024-06-18

Start date

Unknown

Completion date

Unknown

Last updated

2024-06-24

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

Conditions

Health Condition 1: E119- Type 2 diabetes mellitus without complications

Interventions

Intervention1: Madhumega Chooranam and Metformin: Internal: 2 Capsules of Madhumega Chooranam to be given orally thrice a day before food With warm water for 48 days and Metformin of 500 mg to be give

Eligibility

Inclusion criteria

Inclusion criteria: Patients diagnosed with Type 2 Diabetes Mellitus with Sugar reports of HbA1c levels 6.5-10 and post prandial blood sugar levels of 150-300 mg/dl. Willing and able to provide informed consent and to comply with the study protocol.

Exclusion criteria

Exclusion criteria: Pregnant and lactating women. Known cases of Pancreatitis, cancer, Tuberculosis, and any other systemic disorders. Patients taking any other Allopathic medications and AYUSH medicines.

Design outcomes

Primary

Measure	Time frame
Significant reduction in the blood sugar level which is assessed by using sugar reports taken before and after the treatment of 48 days. The Synergy to be analyzed by ANOVA test or Calcusyn software.Timepoint: Getting approval from Screening IEC at NIS - 1 month Study Commencement and conduct of the study - 4 months Assessment of blood sugar level for each participant - Before and after the treatment of 48 days Data compilation and analysis of data - 15 days Submission of report and publication - 15 days	—

Measure

Time frame

Significant reduction in the blood sugar level which is assessed by using sugar reports taken before and after the treatment of 48 days. The Synergy to be analyzed by ANOVA test or Calcusyn software.Timepoint: Getting approval from Screening IEC at NIS - 1 month Study Commencement and conduct of the study - 4 months Assessment of blood sugar level for each participant - Before and after the treatment of 48 days Data compilation and analysis of data - 15 days Submission of report and publication - 15 days

—

Secondary

Measure	Time frame
The safety of Combined Siddha & Allopathy medicines to be explored through laboratory investigations such as LFT & RFT taken before & after the treatment of 48 days.Timepoint: Getting approval from Screening IEC at NIS 1 month Study Commencement & conduct of the study 4 months Assessment of laboratory investigations such as LFT & RFT for participants taking Metformin & Madhumega chooranam Before & after the treatment of 48 days Data compilation & analysis of data 15 days Submission of report & publication 15 days	—

Measure

Time frame

The safety of Combined Siddha & Allopathy medicines to be explored through laboratory investigations such as LFT & RFT taken before & after the treatment of 48 days.Timepoint: Getting approval from Screening IEC at NIS 1 month Study Commencement & conduct of the study 4 months Assessment of laboratory investigations such as LFT & RFT for participants taking Metformin & Madhumega chooranam Before & after the treatment of 48 days Data compilation & analysis of data 15 days Submission of report & publication 15 days

—

Countries

India

Contacts

Public ContactDr S Murugesan

National Institute of Siddha

ss.drss@gmail.com9841108269

Outcome results

None listed

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