“PRAKRITI- A RISK FACTOR FOR MEDO ROGA (ADIPOSOPATHY): WHO STEPS BASED NIDANATMAKA STUDY AND RANDOMIZED UPASHAYATMAKA (CLINICAL) TRIAL OF TRYUSHANADI GUGGULU AND NAVAKA GUGGULUâ€
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- patients of both sexes between age group 18 to 60 years of medoroga will be selected for relieving sign and symptoms
Study Overview
Brief Summary
This is an Open label Randomised single centre trial comparing efficacy of ayurvedic drugs Tryushanadi Guggulu and Navaka Guggulu in the management of Medoroga (adiposopathy). Patient of both sexes between age 18 to 60 years of medoroga will be selected for relieving sign and symptoms. 60 clinically diagnosed and confirmed patients will be randomly divided into two groups for administration of trial drugs. In group I, 30 patients will be administered trial drug tryushanadi guggulu in the dose of 1 gm BD orally for 4 weeks. In group II, 30 patients will be administered trial drug navaka guggulu in the dose of 1 gm BD orally for 4 weeks.All the patients registered for the clinical trial will be asked for any changes in their clinical manifestations and growing feeling of well being. Conclusion- to compare the efficacy of both the drugs.
Study Design
- Study Type
- Interventional
- Allocation
- Coin toss, Lottery, toss of dice, shuffling cards etc
- Masking
- Open Label
Eligibility Criteria
- Ages
- 18.00 Year(s) to 60.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •1-SUBJECTS OF AGE
- •60 YEARS. 2-SUBJECTS OF EITHER SEX. 3-SUBJECTS FOUND TO BE SUFFERING WITH MEDOROGA IN THE NIDANATMAKA STUDY ON THE BASIS OF PARAMETERS SUCH AS ADIPOSOPATHY & DYSLIPIDEMIA AS WELL AS THE AYURVEDIC PARAMETERS AND THEREAFTER CONSENTING TO PARTICIPATE IN THE DRUG TRIAL AND NOT FALLING IN THE EXCLUSION CRITERIA WILL BE INCLUDED.
Exclusion Criteria
- •1-Patients having diabetes mellitus, malignant hypertension and other malignant disorders.
- •2-Patient having Hypersensitivity, anorexia nervosa, history of Coronary artery disease, Congestive heart failure (CHF), arrhythmias, stroke, cardiac disorders, and those receiving Mono amino oxidase inhibitors (MAOIs ) etc.
- •3-Pregnant and lactating mothers.
- •4-Patients having any hormonal disturbances like hypothyroidism.
- •5-Patients not complying with the directions of the physician.
- •6-BMI > 40 kg/m2 7-Patient with major complications and in requirement of emergency treatment.
Outcomes
Primary Outcomes
patients of both sexes between age group 18 to 60 years of medoroga will be selected for relieving sign and symptoms
Time Frame: 4 weeks.
Secondary Outcomes
- Asses the comparative efficacy between Tryushanadi Guggulu and Navaka Guggulu in case of medoroga.(4 weeks)