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Clinical Trial Details

Trial ID: L7105
Source ID: NCT05451147
Associated Drug: Chhinnavahni Kashaya Vati Along With Agnimantha Kwatha
Title: A Comparative Study of the Effect of Ayurvedic Drugs and Metformin in the Management of Diabetes Mellitus (Type II)
Acronym:
Status: COMPLETED
Study Results: NO
Results:
Conditions: Diabetes Mellitus, Type 2
Interventions: DRUG: Chhinnavahni Kashaya Vati along with Agnimantha Kwatha|DRUG: Metformin Hydrochloride
Outcome Measures: Primary: OBJECTIVE PARAMETERS, 1. Blood sugar fasting in Milligrams per decilitre, Change from Baseline at End of trial [3 month]|OBJECTIVE PARAMETERS, Blood sugar post prandial Milligrams per decilitre, Change from Baseline at End of trial [3 month]|OBJECTIVE PARAMETERS, Glycosylated Haemoglobin (HbA1c in %), Change from Baseline at End of trial [3 month] | Secondary: SUBJECTIVE PARAMETERS, Polyurea (excessive urine) grading from 0 to 3, Change from Baseline at End of trial [3 month]|SUBJECTIVE PARAMETERS, Unclear / turbid urine grading from 0 to 3, Change from Baseline at End of trial [3 month]|SUBJECTIVE PARAMETERS, Polyphagia( excessive hunger) grading from 0 to 3, Change from Baseline at End of trial [3 month]|SUBJECTIVE PARAMETERS, Polydipsia (excessive thirst) grading from 0 to 3, Change from Baseline at End of trial [3 month]|SUBJECTIVE PARAMETERS, Exhaustion / tiredness grading from 0 to 3, Change from Baseline at End of trial [3 month]|SUBJECTIVE PARAMETERS, Polyneuritis (numbness / tingling/ burning of soles) grading from 0 to 3, Change from Baseline at End of trial [3 month]|SUBJECTIVE PARAMETERS, Cramps while walking/calf muscle pain grading from 0 to 3, Change from Baseline at End of trial [3 month]|SUBJECTIVE PARAMETERS, Constipation grading from 0 to 3, Change from Baseline at End of trial [3 month]|SUBJECTIVE PARAMETERS, Excessive Sweating grading from 0 to 3, Change from Baseline at End of trial [3 month]|SUBJECTIVE PARAMETERS, Excessive Sleeping grading from 0 to 3, Change from Baseline at End of trial [3 month]|SUBJECTIVE PARAMETERS, DSQ grading from 0 to 3, Change from Baseline at End of trial [3 month]
Sponsor/Collaborators: Sponsor: A & U Tibbia College Karol Bagh
Gender: ALL
Age: ADULT
Phases: PHASE3
Enrollment: 48
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2018-09-03
Completion Date: 2019-04-30
Results First Posted:
Last Update Posted: 2022-07-11
Locations: A and U Tibbia College, Delhi, 110005, India
URL: https://clinicaltrials.gov/show/NCT05451147