CTRI/2021/04/032552Not yet recruitingNot Applicable
A COMPARATIVE STUDY ON THE EFFECT OF ERANDA KSHAR YOGA AND TRYUSHNADI GUGGULU IN THE MANAGEMENT OF MEDOROGA W.S.R. TO DYSLIPIDEMIA
Ayurvedic and Unani Tibbia College and Hospital1 site in 1 country60 target enrollmentStarted: June 4, 2021Last updated:
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- To evaluate the clinical efficacy of Tryushnadi Guggulu and Eranda kshar yoga in management of dyslipidemia.
Study Overview
Brief Summary
Number of dyslipidemia patients are increasing in societies on analarming rate. Dyslipidemiais highly prevalent and is closely related to coronary heart disease which is the most commoncause of death. So a search for holistic and alternative intervention for treating early dyslipidemia is necessary which might not have side effects. This trial tries to search these quests.
Study Design
- Study Type
- Interventional
- Allocation
- Other
- Masking
- Open Label
Eligibility Criteria
- Ages
- 18.00 Year(s) to 60.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •a) Patients between the age group of 18-60 years of either sex.
- •b) Willing and able to participate in the study for 90 days.
- •c) Patients having Serum Cholesterol 201-400mg/dl, Serum Triglycerides 151- 400 mg/dl LDL Cholesterol 131-250 mg/dl, HDL Cholesterol <40mg/dl.
- •d)Patients with strictly controlled Diabetes Mellitus (HbA1c less than or equal to 7%).
Exclusion Criteria
- •Patients having medical history of- a)Patients who have a past history of Atrial Fibrillation, Acute Coronary Syndrome, Myocardial Infarction, congestive heart failure, Stroke or severe Arrhythmia, Unstable angina in the last six months.
- •b)Patients on prolonged (>6weeks) medication with corticosteroids, antidepressants, anticholinergics, immunosuppressant, estrogen replacement therapy etc.
- •or any other drugs that may have an influence on the outcome of the study and patients on oral contraceptives.
- •c)Patients with poorly controlled hypertension (systolic >140 and diastolic >90 mm of Hg) despite of antihypertensive agents.
- •d)Patients with evidence of malignancy.
- •e)Hypersensitivity to any of the trial drugs or their ingredients.
- •f)Patients who have completed participation in any other clinical trial drugs or their ingredients in one -month period.
- •g)Patients who have received any cholesterol lowering medication (allopathic drug) within last two weeks.
- •h)Pregnancy and Lactating mother.
Outcomes
Primary Outcomes
To evaluate the clinical efficacy of Tryushnadi Guggulu and Eranda kshar yoga in management of dyslipidemia.
Time Frame: 3 Months
Secondary Outcomes
- To evaluate the safety of Tryushnadi Guggulu and Eranda kshar yoga in management of dyslipidemia.(90 Days)
Investigators
Study Sites (1)
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