Effectiveness of Poly Herbal Tea in the management of Diabetes Mellitus type 2.

Phase 2

Not yet recruiting

Conditions: Type 2 diabetes mellitus. Ayurveda Condition: PRAMEHAH,

Registration Number: CTRI/2024/07/070882

Lead Sponsor: Dr Sathwik M S

Brief Summary: A minimum of 200 subjects fulfilling inclusion criteria will be selected for the study after subjecting them through clinical examination as per the proforma prepared for the study irrespective of gender, religion and socioeconomic status and assigned into following 2 groups by alternative allocation method (1&2)

group 1: 100 subjects who are on Antidiabetic drugs will be continued same dose. if new case is coming under study will be administered with ayurvedic anti diabetic drugs for 3 months.

group 2: 100 subjects will be given karavellakadi herbal tea as part of daily diet twice a day along with antidiabetic drugs which the subject already taking will be continued in same dose.

The stored herbal ingredients will be packed in to tea bags separately, each tea bag weighing 6g, customized tea bag boxes will be made to keep tea bags according to need and distribution.

preparation of herbal tea ( by the subjects under study) : 6g of herbal tea bag is dipped in 50 ml of hot water for 5 minutes (both morning and evening) 7am and 7pm

Data will be collected using case report form designed by incorporatingall aspects ( Ayurvda and modern medicine) for the study. this collected data will be tabulated and analyzed using SPSS version 20 and analyzed using following statistical test

Detailed Description: Not available

Recruitment & Eligibility

Status: Not Yet Recruiting

Sex: All

Target Recruitment: 200

Inclusion Criteria

1.Subjects fulfilling at least one of the diagnostic criteria 2.Age: 30 year and above 3.subject Irrespective of the gender, religion and socio-economic status 4.subject Willing to give written consent.

Exclusion Criteria

Insulin dependent subjects.
2.Known case of Diabetic nephropathy 3.Known case of Ketoacidosis 4.Known case of Cerebrovascular diseases 5.Women in Pregnancy/lactation 6.
Subjects with other systemic disorders such as a)P.C.O.D b)Thyroid Dysfunction.
c)C.A d)Ischemic Heart Disease.
7.Known case of Mentally ill.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Effect of Herbal Tea in the symptoms of Diabetes Mellitus Type 2	Effect of Herbal Tea in symptoms of Diabetes Mellitus type 2, after 3 months

Secondary Outcome Measures

Name	Time	Method
Compare effect of Poly Herbal Tea in symptoms of Diabetes Mellitus Type 2 in future	Compare effect of Poly Herbal Tea in symptoms of Diabetes Mellitus Type 2 after 3 months

Trial Locations

Locations (2): Sidramappa Danigond Memorial Trusts Ayurvedic Medical College and Hospital, Terdal
🇮🇳
Bagalkot, KARNATAKA, India
Sri Darmasthala Manjunatheswara College of Ayurveda and Hospital
🇮🇳
Hassan, KARNATAKA, India
Sidramappa Danigond Memorial Trusts Ayurvedic Medical College and Hospital, Terdal
🇮🇳Bagalkot, KARNATAKA, India
Dr Sathwik M S
Principal investigator
9538141275
drsathwikms@gmail.com