Comparision study of two poly herbal formulation in type 2 diabetes mellitus (prameha)

Phase 2

Conditions: Health Condition 1: E119- Type 2 diabetes mellitus without complications

Registration Number: CTRI/2023/06/053817

Lead Sponsor: ATIONAL INSTITUTE OF AYURVEDA,DEEMED TO BE UNIVERSITY

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Yet Recruiting

Sex: Not specified

Target Recruitment: 0

Inclusion Criteria

INCLUSION CRITERIA:â??

1. Patients willing to sign Consent Form for the clinical trial.

2. Patients between the age group of 18-70 years, irrespective of sex, caste, religion and socioeconomic status.

3. Patients who fulfill the diagnostic criteria of Pitta-kaphaja Prameha explained in Ä?yurvedika classics and Diagnostic criteria of Diabetes Mellitus Type-II ICMR guidelines 2018 -

ï?·Symptoms of diabetes plus casual or random plasma glucose >= 200 mg/dl (Casual means without regard to time of last meal).

ï?·PPBS >180mg/dl with upper range of 300 mg/dl.

ï?·Fasting plasma glucose >= 126 mg/dl with upper range of 200 mg/dl.

ï?·Glycated Haemoglobin >= 6.5% with upper range of 11.5%.

Exclusion Criteria

EXCLUSION CRITERIA:-

1.Patients below 18 and after 70 years.

2.Cases with deformities that requires surgical treatment.

3.Patients with complications and contraindicated for treatment in Ä?yurvedika and modern texts.

4.Patients of Diabetes Mellitus Type1

5.Patients on allopathic anti-diabetic drug.

6.Malignancy, other endocrinal disorders, chronic infectious diseases etc.

7.Pregnant and lactating mother.

Patients having any serious illness like cardiovascular diseases, renal diseases etc.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Primary outcome: <br/ ><br>Improvement in sign and symptoms of the disease and changes in investigation parameters i.e. FBS, PPBS, HbA1c and Urine R/MTimepoint: 60 DAYS((BEFORE TREATMENT AND AFTER TREATMENT))

Secondary Outcome Measures

Name	Time	Method
Secondary outcome: <br/ ><br>Improvement in quality of life as per Ä?yurvedika text in terms of Agni, Bala, Nidra, Kostha suddhi etc. and changes in other Lab. Investigation LFT, RFT, CBC,ESR,LIPID PROFILE etc.Timepoint: 60 DAYS(BEFORE TREATMENT AND AFTER TREATMENT)