Effect of Herbal medicine, Allopathic medicine and lifestyle modification on newly diagnosed diabetes.

A Randomized, Open-Labelled, active controlled, prospective clinical study to evaluate the Anti-Diabetic activity of a Standardized Ayurvedic Herbal Formulation (CTE Capsule) as compared to Standard Oral Hypoglycemic Therapy (with Metformin and Vildagliptin) in Newly Diagnosed type-2 Diabetic Patients. - NIL

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2023/09/057282

Enrollment

120

Registered

2023-09-06

Start date

Unknown

Completion date

Unknown

Last updated

2025-04-28

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. 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

Exclusion criteria

Exclusion criteria: 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.

Design outcomes

Primary

Measure	Time frame
Reduction in HbA1c from baseline Timepoint: 180 days	—

Secondary

Measure	Time frame
Improvement in Signs & Symptoms of DM & Prameha 2. Reduction in BSL, Serum Insulin from baseline. 3. Reduction in Lipid profile from baseline 4. Reduction in BMI & waist circumference from baseline 5. Reduction in Diabetes Symptoms Questionnaire (DSQ) score from base line Timepoint: 180 days	—

Countries

India

Contacts

Public ContactDr Milind Nikumbh

MUHS,Nashik

provc@muhs.ac.in9890000503

Outcome results