Effect of Herbal medicine, Allopathic medicine and lifestyle modification on newly diagnosed diabetes.
- Conditions
- Health Condition 1: E119- Type 2 diabetes mellitus without complications
- Registration Number
- CTRI/2023/09/057282
- Lead Sponsor
- Maharashtra University of health sciences Nashik
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
1. Newly diagnosed T2DM with any symptom of Polyuria, Polydipsia, Polyphagia,
Bodyache, Giddiness, Polyneuritis, Fatigue,
Matted hair / entangled hair,
Sweet taste in mouth,
Numbness of Hands & Legs,
Burning sensation of hands & legs,
Dryness of mouth,
Dryness of palate,
Dryness of throat,
Polydipsia,
Increased bodily wastes,
Stickiness/excessive excreta at body orifices,
Burning sensation of body,
Numbness of body parts,
Tingling sensation,
Urine afflicted with symptoms as in urinary diseases,
Foul smell of body,
Always feeling sleepy,
Always feeling drowsy,
2. HbA1c 6.5 to 8.5
3. BMI More than 23 Upto 40
4. Not taking any OHA
5. Subjects of either sex, 18-60 years
6. Subjects who agree to participate in the study and submit a written informed consent
form
1.Known Cases of type I DM
2. Patients of gestational diabetes
3. Any unstable Heart disease
4. Pregnant / Lactating women.
5. Alcoholics and/or drug abusers
6. Patients with evidence of malignancy
7. Patients suffering from major systemic illness necessitating long term drug treatment
(Rheumatoid arthritis, Psycho-Neuro, endocrinal disorders, etc.)
8. Patients who have completed participation in any other clinical trial during the past
one (01) month.
9. Any other condition which the Investigator thinks may jeopardize the study.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Reduction in HbA1c from baseline <br/ ><br>Timepoint: 180 days <br/ ><br>
- Secondary Outcome Measures
Name Time Method Improvement in Signs & Symptoms of DM & Prameha <br/ ><br>2. Reduction in BSL, Serum Insulin from baseline. <br/ ><br>3. Reduction in Lipid profile from baseline <br/ ><br>4. Reduction in BMI & waist circumference from baseline <br/ ><br>5. Reduction in Diabetes Symptoms Questionnaire (DSQ) score from base line <br/ ><br>Timepoint: 180 days