A clinical trial to check efficacy of vanga shilajatu in madhumeha (type 2 diabetes mellitus)

An open label randomized clinical trial to evaluate the efficacy of vanga shilajatu in madhumeha with special reference to type 2 diabetes mellitus

Status

Active, not recruiting

Phases

Phase 2Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2023/07/055031

Enrollment

Registered

2023-07-10

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 willing for clinical trials and ready to give written consent. 2. Patients with age between 25-60yrs of either sex. 3. Patients possessing signs and symptoms of Madhumeha (Diabetes Mellitus). 4. Diagnosed & confirmed cases of Madhumeha on the basis of Diagnostic criteria for diabetes.

Exclusion criteria

Exclusion criteria: 1. Patients not willing for the clinical trial. 2. Patient not fulfilling the inclusion criteria. 3. Patients below the age of 25 years and above the age of 60 years 4. Fasting Blood Sugar Level 200 mg/dl 5. Post Prandial Blood Sugar Level 300 mg/dl 6. HbA1c 7%. 4. Patients of Insulin dependent Diabetes Mellitus (IDDM) 5. Patients with diabetic complications such as impaired renal functions. 6. Patients suffering from Secondary Diabetes. 7. Gestational diabetes. 8. Pregnant ladies and lactating mothers.

Design outcomes

Primary

Measure	Time frame
Changes in symptoms and lab test (FBS, PPBS, KFT, SGOT, SGPT, Urine routine and microscopic) will be analyzed on each 7th days during treatment and post treatment again changes in all symptoms and lab test (FBS, PPBS, KFT, SGOT, SGPT, Urine routine and microscopic, Lipid Profile, CBC, HbA1c) will be examined to evaluate the effect of treatment on particular patient.Timepoint: Treatment Duration 28 days Follow up on 7th, 14th,21st and 28th day.	—

Measure

Time frame

Changes in symptoms and lab test (FBS, PPBS, KFT, SGOT, SGPT, Urine routine and microscopic) will be analyzed on each 7th days during treatment and post treatment again changes in all symptoms and lab test (FBS, PPBS, KFT, SGOT, SGPT, Urine routine and microscopic, Lipid Profile, CBC, HbA1c) will be examined to evaluate the effect of treatment on particular patient.Timepoint: Treatment Duration 28 days Follow up on 7th, 14th,21st and 28th day.

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Secondary

Measure	Time frame
1. To study the effect of drug on clinical parameter & biochemical finding associated with Madhumeha Madhumeha (Diabetes Mellitus) 2. To advise preventive measures to check the occurrence of disease individuals and masses. 3. To standardize an ayurvedic line of treatment both drug and dose which may have an effective role in management of patients of Madhumeha. 4. To explain the Madhumeha on the basis of critical review in classic text of Ayurveda and with the help of modern literature. 5. To provide cheap, safe and effective treatment from Ayurveda to Madhumeha patients. Timepoint: 2 years	—

Measure

Time frame

1. To study the effect of drug on clinical parameter & biochemical finding associated with Madhumeha Madhumeha (Diabetes Mellitus) 2. To advise preventive measures to check the occurrence of disease individuals and masses. 3. To standardize an ayurvedic line of treatment both drug and dose which may have an effective role in management of patients of Madhumeha. 4. To explain the Madhumeha on the basis of critical review in classic text of Ayurveda and with the help of modern literature. 5. To provide cheap, safe and effective treatment from Ayurveda to Madhumeha patients. Timepoint: 2 years

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Countries

India

Contacts

Public ContactNeelam yadav

Shri krishna government ayurvedic college and hospital, kurukshetra

mehranilam@gmail.com9671368058

Outcome results