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To check the effectiveness of GCSNR 01 In Madhumeha (Diabetes type 2) patients.

Clinical Study To Evaluate The Efficacy Of GCSNR 01 In The Management Of Madhumeha

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2023/05/052975
Enrollment
130
Registered
2023-05-22
Start date
Unknown
Completion date
Unknown
Last updated
2023-05-29

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

Interventions

None listed

Sponsors

Seth Sakharam Nemchand Jain Ayurved Rugnalya Trust Solapur
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Newly diagnosed or recently diagnosed (last 6 months) Subjects of Madhumeha according to classical sign and symptoms. 2. Subjects having any three of seven subjective criteria will be included. 3. Subjects having any two of three objective criteria will be included. 4. Subjects of madhumeha with age group of 25 to 65 years with irrespective of sex, religion and socio-economic conditions. 5. Blood sugar fasting >=110 mg/dl and 6. Blood Sugar PP>=160 mg/dl and 7. HbA1c more than 5.7% up to 9%.

Exclusion criteria

Exclusion criteria: 1. Known case of Diabetes mellitus with renal failure, and other Diabetic complications (neuropathy, nephropathy etc.) 2. Subjects known case of other systemic diseases like AIDS and Carcinoma, VDRL etc.

Design outcomes

Primary

MeasureTime frame
To develop a drug for Ayurvedic management of Diabetes Mellitus. To access effect on different clinical parameters such as generalized weakness, polypepsia, polydipsia etc. of Diabetes Mellitus. To access effect on different biochemical parameters specifically HbA1c and BSL F & PP. To access the comparative efficacy of study drug with conventional drug Metformin. Timepoint: 90 days

Secondary

MeasureTime frame
To study nidanpanchak of Madhumeha. To propose the etiopathogenesis of Diabetes Mellitus from ayurvedic point of view. To propose possible mode of action of trial drug. To review the modern literature on Diabetes Mellitus in detail. To note any coincidental finding.Timepoint: 90 days with follow up on 30th day, 60th day, 90th day

Countries

India

Contacts

Public ContactDr Santosh Irayya Swami

Seth Govindji Raoji Ayurved Mahavidyalaya, Solapur

santosh.swami@sgrayurved.edu.in9422957234

Outcome results

None listed

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