Effectiveness of Nishatriphala Ghan Capsule along with Metformin and Dietery & lifestyle changes in Managing Type 2 Diabetes Compared to Metformin and Lifestyle Changes Alone.

Add on efficacy of Nishatriphala Ghan Capsule with Metformin and DSDL in comparison to Metformin and DSDL in the management of Madhumeha (Type-2 Diabetes Mellitus) A Comparative Randomized Clinical Trial. - NIL

Status

Active, not recruiting

Phases

Phase 2Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2024/08/072328

Enrollment

Registered

2024-08-12

Start date

Unknown

Completion date

Unknown

Last updated

2024-08-19

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: Patients :- 1)Of either gender in the age group of 26-60 years with classical signs and symptoms of Madhumeha (Type 2 DM). 2)Fulfilling the General Diagnostic Criteria (GDC) for diabetes mellitus along with dyslipidemia. 3)Willing to follw DSDL. 4)Diagnosed with T2DM(less than 5yrs)taking conventional medicine(Metformin) 5)With Blood Sugar Range- Random blood sugar level (RBS) more than or equal to 200 mg/dl up to 300mg/dl or/and Fasting blood sugar (FBS) more than or equal to 126 mg/dl up to 180 mg/dl or/and Postprandial blood sugar (PPBS) more than or equal to 200 mg/dl up to 300 mg/dl or/and Glycosylated haemoglobin range 6.5%-9.5%. 6)With Deranged Lipid Profile :- Cholesterol Total more than200 mg/dl or/and Triglycerides-TGL more than150 mg/dl or/and Cholesterol HDL less than 40 mg/dl or/and Cholesterol LDL more than100 mg/dl

Exclusion criteria

Exclusion criteria: 1)Patients taking insulin either type 1 or type 2 DM. 2)Pregnant women/ lactating mothers. 3)Emergency conditions in cases of DM. 4)Complications of type 2 DM. 5)Patients with other diseases such as chronic liver disease, thyroid disorders, hypertension, CKD, heart diseases etc. 6)Patients were reported being hypersensitive to the proposed trial drug. 7)Patient taking only Ayurvedic medicine for Madhumeha. 8)Patient taking Conventional medicine for T2DM other than Metformin. 9)Participation in other clinical studies in the past 12 weeks. 10)For any reason, the investigator may consider a subject inappropriate for participation in this study.

Design outcomes

Primary

Measure	Time frame
1.20% Reduction in the level of Glycosylated haemoglobin(HbA1c),FBS&PPBS. 2.Significant improvement in the signs and symptoms of Madhumeha. Secondary Outcome:- 1. Improvement in lipid profile. 2. Improvement in urine analysis. 3. Improvement in the quality of life. Timepoint: 0th Day 30th Day 60th Day 90th Day 120th Day	—

Secondary

Measure	Time frame
1. Improvement in lipid profile. 2. Improvement in urine analysis. 3. Improvement in the quality of life. Timepoint: 0th Day 30th Day 60th Day 90th Day 120th Day	—

Countries

India

Contacts

Public ContactDr Raja Ram Mahto

All India Institute Of Ayurveda

mahtorajaram88@gmail.com8877033663

Outcome results