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Clinical Trials/CTRI/2024/05/067024
CTRI/2024/05/067024Not yet recruitingPhase 3 4

Randomized comparative study to evaluate the efficacy of Mustakadi Yoga and Arjuna Churna in management of Medodushti Dyslipidemia

Chaudhary Brahm Prakash Ayurved Charak Sansthan1 site in 1 country52 target enrollmentStarted: May 21, 2024Last updated:

Trial Snapshot

Phase
Phase 3 4
Status
Not yet recruiting
Sponsor
Enrollment
52
Locations
1
Primary Endpoint
Reduction in the haematological parameters of Dyslipidemia

Study Overview

Brief Summary

Dyslipidemia is one of the major escalating public health challenge worldwide, arising as a result of combination of some genetic factors and more importantly certain environmental factors like sedentary lifestyle, increased urbanization, nutritional advancement accompanying economic development, substance abuse and other associated medical conditions. According to Acharya Sushruta, when there is excess deposition of Medadhatu in body it may produce excessive greasiness in the body which results in a very bad smell, enlargement of abdomen and flanks (pendular hanging), cough, breathlessness are some other symptoms. Samprapti of is Medadushti is when accumulated Meda dhatu blocks Strotasa’s other Dhatu’s are not properly nourished as a result Meda Dhatu further gets increased.x The person with Medo Roga will have Kshudra Shwas (breathlessness), Trisha (excessive thirst), Moha, Swapna (excessive sleep), Krathana (Sudden obstruction of breath), Sadana (looseness of the body) Kshuta (Excessive hunger) ,Sweda (excessive sweating), Daurgandhya(foul body smell), Alpa prana( Fatigue), Alpa Maithuna ( loss of libido)The prevalence of Dyslipidemia varies around the world depending on the age and ethnicity of population studied. In general, its prevalence increases with age. Though it affects both the gender but studies have shown that males are more predisposed than females. The Indian council of medical research Sevillians project reported a prevalence of Dyslipidemia of 37.5% amongst adults aged between 15-64 years. the present study aims to evaluate the role of mustakadi yoga and arjuna churna in the management of dyslipidemia. total number of patients is 52,26 in each group. in group A, mustakadi yoga will be administered at a dose of 3gm BD with luke warm water empty stomach in early morning and evening.  In group B, arjuna churna is adminstered at a dose of 3gm BD with luke warm water empty stomach in early morning and evening.The design of study is a single centred ,open-labelled,Randomized,comparative,interventional study

Study Design

Study Type
Interventional
Allocation
Randomized
Masking
None

Eligibility Criteria

Ages
20.00 Year(s) to 60.00 Year(s) (—)
Sex
All

Inclusion Criteria

  • 1 Diagnosed and confirmed cases of Dyslipidemia based on investigation 2 Patients with total cholesterol above 200mg/dl 3 Patients with triglycerides above 150mg/dl or HDL below 40mg/dl, or LDL 100mg/dl or VLDL above 30mg/dl 4 Patient with any one or more Lakshana of Medodushti 5 Patient between the age group of 20-60 years of either sex who will fulfil the criteria of diagnosis 6 Patient having controlled diabetes mellitus and hypertension 7 Patients willing and able to participate for 8 weeks duration 8 Patients who are ready to give consent with firm home address and contact number which is readily accessible during coarse of trial.

Exclusion Criteria

  • 1 Patient not willing for the trial 2 Patients with total cholesterol above 240mg/dl or LDL cholesterol above 160mg/dl or HDL cholesterol above 60mg/dl 3 Patient with Hypertension (Blood pressure greater than 160/100 mm of Hg) 4 Patient having illness like Tuberculosis, Carcinoma, or major illness like renal or Liver disorders 5 Patient having past-history of Myocardial Infarction, Unstable angina, and congestive cardiac failure 6 Patient below 20 years and above 60 years of age 7 History of hypersensitivity to any trial drug or their ingredients 8 Pregnant females and lactating mothers.

Outcomes

Primary Outcomes

Reduction in the haematological parameters of Dyslipidemia

Time Frame: 75 days

Total Serum Cholesterol greater than or equal to 200mg/dl

Time Frame: 75 days

Serum Triglycerides greater than or equal to 150mg/dl

Time Frame: 75 days

Serum LDL Cholesterol greater than or equal to 100 mg/dl

Time Frame: 75 days

Serum HDL Cholesterol less than 40mg/dl

Time Frame: 75 days

Serum VLDL Cholesterol greater than 40mg/dl

Time Frame: 75 days

Secondary Outcomes

  • Improvements in the signs & symptoms of Medodushti- Dyslipidemia(1 Kshudra Shwasa-Breathlessness)

Investigators

Sponsor
Chaudhary Brahm Prakash Ayurved Charak Sansthan
Sponsor Class
Research institution and hospital
Responsible Party
Principal Investigator
Principal Investigator

Dr Durgesh Kumar

Chaudhary Brahm Prakash Ayurved Charak Sansthan Khera Dabar Najafgarh

Study Sites (1)

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