| CTRI Number |
CTRI/2024/05/067024 [Registered on: 08/05/2024] Trial Registered Prospectively |
| Last Modified On: |
07/05/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Other (Specify) |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effect of Mustakadi Yoga and Arjuna Churna in the management of Medodushti (Dyslipidaemia) |
|
Scientific Title of Study
|
Randomized comparative study to evaluate the efficacy of Mustakadi Yoga and Arjuna Churna in management of Medodushti 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 |
Dr Durgesh Kumar |
| Designation |
MD scholar |
| Affiliation |
Chaudhary Brahm Prakash Ayurved Charak Sansthan Khera Dabar Najafgarh |
| Address |
Room no 108 Department of Kayachikitsa Chaudhary Brahm
Prakash Ayurved Charak Sansthan Khera Dabar Najafgarh
South
West
Delhi
South West
DELHI
110073
India |
| Phone |
9650690308 |
| Fax |
|
| Email |
jangradurgesh007@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Atal Bihari Trivedi |
| Designation |
Associate Professor |
| Affiliation |
Chaudhary Brahm Prakash Ayurved Charak Sansthan Najafgarh |
| Address |
PG Department of Kayachikitsa, Chaudhary Brahm Prakash Ayurved
Charak Sansthan Khera Dabar
South West
DELHI
South West
DELHI
110073
India |
| Phone |
9958046550 |
| Fax |
|
| Email |
abdratal8@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Atal Bihari Trivedi |
| Designation |
Associate Professor |
| Affiliation |
Chaudhary Brahm Prakash Ayurved Charak Sansthan Najafgarh |
| Address |
PG Department of Kayachikitsa, Chaudhary Brahm Prakash Ayurved
Charak Sansthan Khera Dabar
South West
DELHI
DELHI
110073
India |
| Phone |
9958046550 |
| Fax |
|
| Email |
abdratal8@gmail.com |
|
|
Source of Monetary or Material Support
|
| Chaudhary Brahm Prakash Ayurved Charak Sansthan khera dabar Najafgarh south west new delhi india 110073 |
|
|
Primary Sponsor
|
| Name |
Chaudhary Brahm Prakash Ayurved Charak Sansthan |
| Address |
Chaudhary Brahm Prakash Ayurved Charak Sansthan Khera Dabar Najafgarh south west New Delhi india 110073 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| Dr Durgesh Kumar |
Chaudhary Brahm Prakash Ayurved Charak Sansthan |
Room no 108 Department of Kayachikitsa Chaudhary Brahm
Prakash Ayurved Charak Sansthan Khera Dabar Najafgarh
South
West
Delhi 110073
South West
DELHI |
9650690308
jangradurgesh007@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee Chaudhary Brahm Prakash Ayurved Charak Sansthan |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:E782||Mixed hyperlipidemia. Ayurveda Condition: MEDOVAHASROTODUSHTIH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Arjuna Churna , Reference: Bhavaprakash Nighnatu, Route: Oral, Dosage Form: Churna/ Powder, Dose: 3(g), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 75 Days, anupAna/sahapAna: Yes(details: Lukewarm water ), Additional Information: - | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Mustakadi Yoga , Reference: Charak sutra sthana, Route: Oral, Dosage Form: Churna/ Powder, Dose: 3(g), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 75 Days, anupAna/sahapAna: Yes(details: Luke warm water ), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
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 |
|
| ExclusionCriteria |
| Details |
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 |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Reduction in the haematological parameters of Dyslipidemia
Total Serum Cholesterol greater than or equal to 200mg/dl
Serum Triglycerides greater than or equal to 150mg/dl
Serum LDL Cholesterol greater than or equal to 100 mg/dl
Serum HDL Cholesterol less than 40mg/dl
Serum VLDL Cholesterol greater than 40mg/dl
|
75 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Improvements in the signs & symptoms of Medodushti- Dyslipidemia
1 Kshudra Shwasa-Breathlessness
2 Trishna-Polydipsia
3 Nidraadhikya-Excessive sleep
4 Kshudha Atimatra-Excessive hunger
5 Swedadhikya-Excessive sweating
6 Daurgandhya-Bad odour of body
7 Alpa Prana-Fatigue |
75 days |
|
|
Target Sample Size
|
Total Sample Size="52"
Sample Size from India="52"
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 3/ Phase 4 |
|
Date of First Enrollment (India)
|
21/05/2024 |
| 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 Yet Recruiting |
| 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 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 |