A clinical trial to assess efficacy of saptarangi bhavit vachadi ghana in diabetes mellitus type 2

Single arm clinical trial to assess efficacy and safety of saptarangi bhavit vachadi ghana in diabetes mellitus type 2 associated with metabolic syndrome - Nil

Status

Active, not recruiting

Phases

Phase 2Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2023/07/055334

Enrollment

Registered

2023-07-18

Start date

Unknown

Completion date

Unknown

Last updated

2023-07-25

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

None listed

Eligibility

Inclusion criteria

Inclusion criteria: 1) Patients possessing sign and symptoms of Prameh (Diabetes mellitus) 2) Patient fulfilling the diagnostic criteria for Diabetes Mellitus framed by AMARICAN DIABETES ASSOCIATION. 3) FBS 4) HbA1c 5) Patient willing for clinical trials and ready to give written consent.

Exclusion criteria

Exclusion criteria: 1) Patients not fulfilling the inclusion criteria 2) Patients of Sahaj Prameha and IDDM (type 1 diabetes mellitus) . 3) Pregnancy and lactating mothers, Gestational diabetes. 4) Patient with diabetic complications such as impaired renal functions. 5) Patient suffering from Secondary Diabetes. 6) Patients suffering from any serious systemic disorders such as uncontrolled hypertension, tuberculosis, carcinoma and HIV. 7) Patient below 30 years & above 60 years of age

Design outcomes

Primary

Measure	Time frame
The effect of drug will be analysed on 1st 7th 14th 21st 28th 35th & after treatment by the means of change in subjective criteria & objective criteria (RBS, FBS, PPBS, HbA1c)Timepoint: Approx 45 days per patient	—

Secondary

Measure	Time frame
Objectives: â?¢To know the efficacy & safety of this saptarangi bhavit vachadi ghana in diabetes mellitus type 2 associated with metabolic syndrome â?¢Detailed study of 7 drugs included in this saptarangi bhavit vachadi ghana. â?¢ Detailed Study of Diabetes mellitus type 2 associated with metabolic syndrome with special reference to Madhumeha. â?¢Preparation of formulation made by these seven Ayurvedic herbs.Timepoint: 1 Year 6 Months	—

Measure

Time frame

Objectives: â?¢To know the efficacy & safety of this saptarangi bhavit vachadi ghana in diabetes mellitus type 2 associated with metabolic syndrome â?¢Detailed study of 7 drugs included in this saptarangi bhavit vachadi ghana. â?¢ Detailed Study of Diabetes mellitus type 2 associated with metabolic syndrome with special reference to Madhumeha. â?¢Preparation of formulation made by these seven Ayurvedic herbs.Timepoint: 1 Year 6 Months

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Countries

India

Contacts

Public ContactAnil Sharma

Shri krishna government ayurvedic college and hospital

anilherbals@gmail.com7016792749

Outcome results