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

Phase 2

Not yet recruiting

Conditions: Type 2 diabetes mellitus without complications. Ayurveda Condition: PRAMEHAH,

Registration Number: CTRI/2023/09/057282

Lead Sponsor: Maharashtra University of health sciences Nashik

Brief Summary: Diabetes is a multi factorial disease with complex multi-organ-multi-target crosstalk in the body. Currently, the theoretical assumptions framing the diabetes management strategies are reductionist and largely focus on reducing hyperglycemia through targeted molecular drugs. While they effectively reduce hyperglycemia, they may not be adequate to address the multifactorial etiopathology, chronicity and systemic complications of diabetes. Therefore, a holistic and systemic approach is essential for its successful management.i Ayurveda has potential in tackling diabetes, through diet and lifestyle, pharmacotherapy, or an appropriate combination of both We hypothesize that an integrative diabetes management strategy, combining holistic principles of Ayurveda, the Indian system of medicine, can play a pivotal role in this context. A personalized treatment approach for patients with diabetes may be possible through Ayurveda. Acceptability and compliance may be better on account of the socio-cultural acceptance of Ayurveda. Synergistic approach of modern medicine and Ayurveda could lead to better outcomes for patients of diabetes as opposed to treatment with either of the two.

Integrative approach of medicinal management can give a better answer to prevent the comorbidities of diabetes as well as obesity. Ayurved has clinically classified the management of diabetes as Thin Diabetic and Obese diabetics. This is a very unique approach of Ayurved to treat diabetes differently in obese and thin individuals. Advanced studies also suggest the difference in the pathophysiology and management of Obese and thin diabetic..

Assessment will be done as follows :

Intervention: a) Group A: Standard OHA Regimen + Standard Dietary Advice

b) Group B: Standard OHA Regimen + Ayurveda Dietary Advice

c) Group C: Standardized Ayurveda Herbal Formulation (CTE Capsules) + Ayurveda Dietary Advice

d) Group D: Standard OHA Regimen + Ayurveda Herbal Standardized Formulation (CTE Capsules) + Ayurveda Dietary Advice Assessment : at baseline, 30 days, 60 days, 90 days, 120 days, 150 days and at the end of 180 days. Study will be conducted on total of 144 subjects for 180 days .The study will be Multicentric.

Detailed Description: Not available

Recruitment & Eligibility

Status: Not Yet Recruiting

Sex: All

Target Recruitment: 120

Inclusion Criteria

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

1.Known Cases of type I DM 2.
Patients of gestational diabetes 3.
Any unstable Heart disease 4.
Pregnant / Lactating women.
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.
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	180 days

Secondary Outcome Measures

Name	Time	Method
Improvement in Signs & Symptoms of DM & Prameha	2. Reduction in BSL, Serum Insulin from baseline.

Trial Locations

Locations (3): Arogyashala Rugnalaya
🇮🇳
Nashik, MAHARASHTRA, India
Chellaram Diabetes Institute
🇮🇳
Pune, MAHARASHTRA, India
SMBT Institute of Medical Sciences and Research Centre
🇮🇳
Nashik, MAHARASHTRA, India
Arogyashala Rugnalaya
🇮🇳Nashik, MAHARASHTRA, India
Dr Shishir Pande
Principal investigator
9420830818
shishir.nsk@gmail.com