Comparision study of two poly herbal formulation in type 2 diabetes mellitus (prameha)
- Conditions
- Type 2 diabetes mellitus without complications. Ayurveda Condition: PRAMEHAH,
- Registration Number
- CTRI/2023/06/053817
- Lead Sponsor
- NATIONAL INSTITUTE OF AYURVEDA,DEEMED TO BE UNIVERSITY
- Brief Summary
· This study is a single centre, openlabel, randomized, interventional, and comparing the safety and efficacy ofTriphalÄdi Kaá¹£Äya50 ml & MustÄdi Kaá¹£Äya50ml.
· Procedure protocol will be followed:
· Patients who fulfill the diagnosticcriteria of Pitta-kaphaja *Prameha* explained in *Āyurvedika*classics and Diagnostic criteria of Diabetes MellitusType-IIICMR guidelines will be selected from nia hospital.
· Patients will be divided in twogroups, each group contains 30 patients, one group will received TriphalÄdiKaá¹£Äya (50 ml) and another group will received MustÄdi Kaá¹£Äya (50ml).
· Allpatients will be followed up fortnightly for 60 days.
· The full details of history &physical examination of patient will be recorded as per the Performa.
· Assessment of Subjective Parameters and objective parameters will be done on 15thday, 30th day, 45th day, 60th day afterinitial assessment.
· The primary outcome measures will be Improvement in sign and symptoms of the disease andchanges in investigation parameters i.e. FBS, PPBS, HbA1c and Urine R/M andthe other Subjective parameters Improvement in quality of life as per *Āyurvedika* text in terms of *Agni, Bala, Nidra, Kosthasuddhi* etc. and changes in other Lab. Investigation LFT, RFT,CBC,ESR,LIPID PROFILE etc.
· Resultswill be analysed with appropriate statistical tests as follow - SubjectiveParameters – Wilcoxon’s paired rank test and Mann Whitney U test.
· Objective Parameters – Paired ‘t’ test andunpaired ‘t’ test.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not Yet Recruiting
- Sex
- All
- Target Recruitment
- 60
- INCLUSION CRITERIA:– 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 Āyurvedika classics and Diagnostic criteria of Diabetes Mellitus Type-II ICMR guidelines 2018.
- Symptoms of diabetes plus casual or random plasma glucose ≥ 200 mg/dl (Casual means without regard to time of last meal). PPBS >180mg/dl with upper range of 300 mg/dl. Fasting plasma glucose ≥ 126 mg/dl with upper range of 200 mg/dl. Glycated Haemoglobin ≥ 6.5% with upper range of 11.5%.
- EXCLUSION CRITERIA:- 1.Patients below 18 and after 70 years.
- 3.Patients with complications and contraindicated for treatment in Āyurvedika 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: 60 DAYS((BEFORE TREATMENT AND AFTER TREATMENT)) Improvement in sign and symptoms of the disease and changes in investigation parameters i.e. FBS, PPBS, HbA1c and Urine R/M 60 DAYS((BEFORE TREATMENT AND AFTER TREATMENT))
- Secondary Outcome Measures
Name Time Method Secondary outcome: Improvement in quality of life as per Āyurvedika text in terms of Agni, Bala, Nidra, Kostha suddhi etc. and changes in other Lab. Investigation LFT, RFT, CBC,ESR,LIPID PROFILE etc.
Trial Locations
- Locations (1)
National Institute of Ayurveda Hospital,jorawar singh gate,Jaipur
🇮🇳Jaipur, RAJASTHAN, India
National Institute of Ayurveda Hospital,jorawar singh gate,Jaipur🇮🇳Jaipur, RAJASTHAN, IndiaDrAbhineshPrincipal investigator8432688966kumawatabhinesh@gmail.com