Standard Controlled Clinical Evaluation of Phaltrikadi Ghanvati in Madhumeha (NIDDM)
Trial Snapshot
- Phase
- Phase 2
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- relief in subjective parameters.
Study Overview
Brief Summary
THIS STUDY IS STANDARD CONTROLLED CLINICAL EVALUATION OF PHALTRIKADI GHANVATI IN MADHUMEHA (NIDDM) FOR AGE GROUP BETWEEN 20 TO 70 YEARS FOR A DURATION OF 90 DAYS. THE STUDY WILL BE CONDUCTED AT UAU GURUKUL CAMPUS HARIDWAR ON 40 PATIENTS. IN THIS STUDY 20 PATIENTS WILL BE ADMINISTERED PHALTRIKADI GHANVATI AND 20 PATIENTS WILL BE ADMINISTERED BGR-34 FOR 90 DAYS. THE ASSESSMENT WILL BE DONE ON THE BASIS OF SUBJECTIVE AND OBJECTIVE PARAMETERS. THE STUDY WILL BE CONDUCTE AT OPD/IPD LEVEL OF PG DEPARTMENT OF KAYACHIKITSA. THE ASSESSMENT WILL BE DONE AT THE INTERVAL OF 30 DAYS OF THE CLINICAL TRIAL AND THE RESULTS OBTAINED WILL BE TABULATED AND STATISTICALLY ANALYZED USING APPROPRIATE TESTS.
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Ages
- 20.00 Year(s) to 70.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •1.Patient willing to sign the consent form.
- •2.Fasting blood glucose level more than or equal to 126mg per dl to less than or equal to 200mg per dl 3.Post prandial blood sugar level more than or equal to 200mg per dl to less than or equal to 300 mg per dl 4.HbA1c more than or equal to 6.5 percentage to less than or equal to 9 percentage.
Exclusion Criteria
- •1.Patients of type 1 Diabetes Mellitus.
- •2.Patients having past history of MI,unstable angina or stroke.
- •3.Patients suffering from AIDS,cancer,tuberculosis,psychiatric illness.
- •4.pregnant and lactating women.
Outcomes
Primary Outcomes
relief in subjective parameters.
Time Frame: 4-6 weeks
1. Prabhutmutrata(polyuria)
Time Frame: 4-6 weeks
2.Trishnadhikya(polydipsia)
Time Frame: 4-6 weeks
3.Kshudhadhikya(polyphagia)
Time Frame: 4-6 weeks
4.Daurbalya(weakness)
Time Frame: 4-6 weeks
5.Kara-pada-taladaha(burning sensation of both palms and feet)
Time Frame: 4-6 weeks
6.Avilmutrata(turbidity in urine)
Time Frame: 4-6 weeks
Secondary Outcomes
- relief in objective parameters.(1.Blood sugar fasting)
Investigators
Rajni
Uttarakhand Ayurved University Gurukul Campus Haridwar Uttarakhand