| CTRI Number |
CTRI/2023/07/055335 [Registered on: 18/07/2023] Trial Registered Prospectively |
| Last Modified On: |
01/07/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A clinical trial to assess efficacy of vachadi yoga in dyslipidemia |
|
Scientific Title of Study
|
A single arm clinical trial to evaluate the efficacy and safety of vachadi yoga in management of dyslipidemia |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dushyant |
| Designation |
PG Scholar |
| Affiliation |
Shri krishna government ayurvedic college and hospital |
| Address |
Room No 33 Department of Dravya Guna Shri krishna government
ayurvedic college and hospital Sec 8 Umri Road
Kurukshetra
Kurukshetra
HARYANA
136118
India |
| Phone |
9729857347 |
| Fax |
|
| Email |
dushy175@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Anil Sharma |
| Designation |
Professor and HOD Department of Dravya Guna |
| Affiliation |
Shri krishna government ayurvedic college and hospital |
| Address |
Room No 33 Department of Dravya Guna Shri krishna government
ayurvedic college and hospital Sec 8 Umri Road
Kurukshetra
HARYANA
136118
India |
| Phone |
7016792749 |
| Fax |
|
| Email |
anilherbals@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Anil Sharma |
| Designation |
Professor and HOD Department of Dravya Guna |
| Affiliation |
Shri krishna government ayurvedic college and hospital |
| Address |
Room No 33 Department of Dravya Guna Shri krishna government
ayurvedic college and hospital Sec 8 Umri Road
HARYANA
136118
India |
| Phone |
7016792749 |
| Fax |
|
| Email |
anilherbals@gmail.com |
|
|
Source of Monetary or Material Support
|
| Shri krishna government ayurvedic college and hospital kurukshetra |
|
|
Primary Sponsor
|
| Name |
Shri krishna government ayurvedic college and hospital |
| Address |
Shri krishna government ayurvedic college and hospital Sec 8 Umri
Road Kurukshetra |
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dushyant |
Shri krishna government ayurvedic college and hospital |
Room No 58 Department of Dravya Guna
Kurukshetra
HARYANA |
09729857347
dushy175@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee Shri Krishna Ayush University |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:E789||Disorder of lipoprotein metabolism, unspecified. Ayurveda Condition: MEDOVAHASROTODUSHTIH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Vachadi Yoga, Reference: Ashtang Hridya sutra sthana adhyay 15, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 1000(mg), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 60 Days, anupAna/sahapAna: No, Additional Information: tablets of Lehsun swaras bhavit vachadi gana will be made each of 500 mg. |
|
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
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 |
|
| ExclusionCriteria |
| Details |
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. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
The effect of drug will be analysed on 1st 15th
30th 45th 60th & after treatment on 70 th day by the
means of change in subjective criteria and
objective criteria (HDL,LDL,Triglyceride,Total Cholestrol) |
Approx 70 days per patient
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
• Preparation of Vachadi Yoga & to assess its efficacy.
• Review of literature of herbs involved in this Vachadi Yoga.
• Detailed study of Dyslipidemia.
• Ayurvedic concept of Dyslipidemia |
1 year & 6 month |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
05/09/2023 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
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 |