Evaluation of safety and efficacy of Pramehakulantaka Rasa in the management of Madhumeha (Diabetes Mellitus TypeII)

Preclinical and clinical evaluation of safety and efficacy of Pramehakulantaka Rasa in the management of Madhumeha w.s.r. to Diabetes Mellitus TypeII

Status

Active, not recruiting

Phases

Phase 1Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2019/05/019339

Enrollment

Registered

2019-05-24

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: E119- Type 2 diabetes mellitus without complications

Interventions

Intervention1: PramehaKulantaka Rasa: Oral administration of Pramehakulantaka Rasa in dose of 500 mg twice in a day with cow milk before meal for 90 days. Control Intervention1: Not Applicable: Not Ap

Eligibility

Inclusion criteria

Inclusion criteria: 1. Patients ready to give concern for the trial & willing to participate in the study for 3 months. 2. Patients between the age group of 31-70 years in either sex. 3. Newly diagnosed & confirmed cases of Mahdumeha (Type II Diabetes Mellitus) not talking allopathic drug or Insulin Therapy. 4. Patients with Fasting Blood Sugar (FBS) in the range of 126mg/dl â?? 250mg/dl or Post Prandial Blood Sugar (PPBS) in the range of 200mg/dl â?? 300 mg/dl and Glycosylated Haemoglobin (HbA1c) 6.5% - 9.0%. 5. Presence of Cardinal symptoms of Diabetes Mellitus eg. (3P- polyuria, polydipsia, polyphagia).

Exclusion criteria

Exclusion criteria: 1. Patients below 31years of age & above 70 years of age. 2. Patients having Type I DM. 3. F.B.S. > 250 mg/dl and P.P.B.S. > 300 mg/dl. 4. Patients of Type II DM who are on insulin therapy and Drug induced DM. 5. Patients on allopathic anti-diabetic drug. 6. DM with complications and Madhumeha with ashadhya upadrava. 7. Patients having any serious illness like cardiovascular diseases, renal diseases, hepatic diseases, malignancy, any other endocrinopathies etc. 8. Pregnant and lactating mother.

Design outcomes

Primary

Measure	Time frame
Changes in the clinical symptoms of Mahdumeha (Type II Diabetes Mellitus)Timepoint: 90 days	—

Secondary

Measure	Time frame
Changes in the objective parameters- F.B.S., P.P.B.S. & HbA1c. Timepoint: 90 Days	—

Countries

India

Contacts

Public ContactDr Deepika Gupta

National institute of Ayurveda

joshirk1964@gmail.com9414322297

Outcome results

None listed

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