A clinical trial to assess efficacy of vachadi yoga in dyslipidemia

Phase 2/3

Not yet recruiting

• Conditions: Disorder of lipoprotein metabolism, unspecified. Ayurveda Condition: MEDOVAHASROTODUSHTIH,

• Registration Number: CTRI/2023/07/055335
• Lead Sponsor: Shri krishna government ayurvedic college and hospital

Brief Summary

Dyslipidemia is a disorder of lipoprotein metabolism, which may include lipoprotein overproduction or deficiency, or both.1 This disorder may manifest as elevated plasma cholesterol, TG or both, or a low plasma concentration of high-density lipoprotein or all three contribute to the development of atherosclerosis.The most common types of dyslipidemia include high levels of low-density lipoprotein (LDL) cholesterol, high levels of triglycerides, and low levels of high-density lipoprotein.In ayurveda, various *aharaj-viharaj nidhan* leads to *agnimandya* (diminished digestive power). This further contributes to the formation of *Ama*.This *ama* accumulates in *Ras-rakta gata dhatu* and leads to increase in the *snigdha ansh*. This abnormal *Ras-rakta dhatu gata snigdha ansh* leads to the obstruction which is prone for occurrence of various diseases.In Ayurveda the herbs such as *Vacha, Nagarmotha, Devdaru, Sunthi, Atish* and *Haritaki* having properties like *Ushna, Tikshna, Katu,* etc. are said to be capable to treat *Ama* and *Rasa-rakta gata Sneha Vridhi* which is the basic reason for the occurrence of most of the diseases.So, these drugs (*Vacha, Nagarmotha, Devdaru, Sunthi, Atish and Haritaki*) have been selected for the present study and further to increase the potency of these drugs, the *bhavna* of *lehsuna swaras* will be given. Thus we decided to this randomized clinical trial on dyslipidemia by using ayurvedic drugsTablets of vachadi yoga will be made each of 500 mg and will be given two tablets twice daily for 60 days. Follow up will be done every 15th day during the treatment. After completion of treatment, patient will be assessed on basis of subjective and Objective parameters and result will be analyzed after using appropriate statistical methods

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2023-01-07
• Study Start: 2023-05-09

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

1. fulfilling the diagnostic criteria (diagnosed with abnormal lipid profile i.e. Total Cholestrol level upto 300mg/dl, LDL level upto200mg/dl, HDL upto 35mg/dl and Triglycerides level upto 500mg/dl) 2) willing to participate in the clinical trial.

Exclusion Criteria

• 1. Age below 25 and above 50 years.
• 2. Patients suffering from type 1 diabetes mellitus and uncontrolled diabetes mellitus or uncontrolled hypertension 3) Drug induced Dyslipidemia 4) Patient having systemic illness like tuberculosis, carcinoma and endocrine disorders or major illness like renal or liver disorder 5) Patient having the past history of myocardial infarction & unstable Angina.
• 6. Patient having clinical features of CCF 7) Patients having a history of untreated thyroid disorder.
• 8. Patients on prolonged medication (>6weeks) with corticosteroids, or any other drugs that may have an influence on the outcome of the study.
• 9. Patients who are currently participating in any other clinical trials (since last 6months).
• 10. Pregnant females and lactating mothers.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The effect of drug will be analysed on 1st 15th	Approx 70 days per patient
30th 45th 60th & after treatment on 70 th day by the	Approx 70 days per patient
means of change in subjective criteria and	Approx 70 days per patient
objective criteria (HDL,LDL,Triglyceride,Total Cholestrol)	Approx 70 days per patient

Secondary Outcome Measures

Name	Time	Method
• Preparation of Vachadi Yoga & to assess its efficacy.	• Review of literature of herbs involved in this Vachadi Yoga.

Trial Locations

Locations (1)

Shri krishna government ayurvedic college and hospital; 🇮🇳 Kurukshetra, HARYANA, India

Shri krishna government ayurvedic college and hospital

🇮🇳Kurukshetra, HARYANA, India

Dushyant

Principal investigator

09729857347

dushy175@gmail.com