A manufacturing process of Swarna Makshika Bhasma and its clinical trial in Diabetes type 2 Patients.

PHARMACEUTICAL STUDY OF SWARNA MAKSHIKA BHASMA AND ITS CLINICAL EFFICACY IN MADHUMEHA (DM TYPE-II) - SMB

Status

Active, not recruiting

Phases

Phase 1Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2015/08/006114

Enrollment

Registered

2015-08-19

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

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

Conditions

Health Condition 1: null- Madhumeha (DM TYPE II) Health Condition 2: E119- Type 2 diabetes mellitus without complications

Interventions

Intervention1: Swarna Makshika Bhasma with Triphala Ghana: Dose: 375mg (125 mg Swarna Makshika Bhasma + 250 mg Triphala Ghana capsule BD orally) Duration: 8 weeks. Follow up: Patients will be review

Eligibility

Inclusion criteria

Inclusion criteria: 1. Patients having classical symptomatology of Madhumeha (Prabhutamutrata, Avilamutrata etc) will be selected from O.P.D. and I.P.D. of I.P.G.T. & R.A., Hospital, Jamnagar. 2. Symptoms of Diabetes (Polyuria, Polydypsia, Polyphagia and Weight loss.) 3. Both the sexes having Age between 30 years to 60 years. 4. Patients having Blood sugar â?? FBS >= 126 mg/dl â?? PPBS >= 200 mg/dl

Exclusion criteria

Exclusion criteria: 1. Age below 30 and above 60 years. 2. Malignant and accelerated Hypertension. 3. Patients having chronic complications of Diabetes Mellitus a. Microvascular: Retinopathy, Neuropathy, & Nephropathy. b. Macrovascular: Coronary artery disease, Peripheral vascular disease & Cerebro-vascular disease. c. Other chronic debilitating diseases like STD etc. 4. Pregnant women. 5. Lactating mothers. 6. Secondary Diabetes mellitus. 7. Patients of any other severe illness.

Design outcomes

Primary

Measure	Time frame
It is expected that the trial drugs will exert a significant action over blood sugar level.Timepoint: up to 8 weeks	—

Secondary

Measure	Time frame
By maintaining the helthy level of BSL, The drug will control conditions associated with Madhumeha(DM TYPE II) like Polyuria, Polydypsia, Polyphagia and Weight loss etc.Timepoint: up to 8 weeks.	—

Countries

India

Contacts

Public ContactDr B J Patgiri

IPGT and RA

patgiri124@gmail.com9426947438

Outcome results

None listed

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