| CTRI Number |
CTRI/2025/01/079456 [Registered on: 24/01/2025] Trial Registered Prospectively |
| Last Modified On: |
23/01/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Other (Specify) [Therapeutic clinical] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effect of Arjuna Kwath and Arogyavardhini vati in management of Medoroga w.s.r Dyslipidemia |
|
Scientific Title of Study
|
Comparative study to evaluate the efficacy of Arjuna Kwath and Arogyavardhini vati in management of Medoroga (Dyslipidemia) A Randomized controlled trial |
| 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 Neha Tyagi |
| Designation |
MD Scholar Kayachikitsa |
| Affiliation |
Chaudhary Brahm Prakash Ayurved Charak Sansthan, Khera Dabar, Najafgarh, New Delhi |
| Address |
Room No 108 PG Department of Kayachikitsa,Chaudhary Brahm Prakash Ayurved Charak Sansthan, Khera Dabar, Najafgarh, New Delhi
South West
DELHI
110073
India |
| Phone |
9205946994 |
| Fax |
|
| Email |
tyagineha9832@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Atal Bihari Trivedi |
| Designation |
Associate Professor |
| Affiliation |
Chaudhary brahm prakash ayurved charak sansthan, Khera Dabar, Najafgarh, New Delhi |
| Address |
PG Department of Kayachikitsa Chaudhary Brahm Prakash Ayurved Charak Sansthan, Khera Dabar, Najafgarh, New 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, Khera Dabar, Najafgarh, New Delhi |
| Address |
PG Department of Kayachikitsa Chaudhary Brahm Prakash Ayurved Charak Sansthan, Khera Dabar, Najafgarh, New Delhi
South West
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 New Delhi 110073 India |
|
|
Primary Sponsor
|
| Name |
Chaudhary Brahm Prakash Ayurved Charak Sansthan |
| Address |
Khera Dabar, New Delhi 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 Neha Tyagi |
Chaudhary Brahm Prakash Ayurved Charak Sansthan |
Room No 108 PG Department of Kayachikitsa,Chaudhary Brahm Prakash Ayurved Charak Sansthan, Khera Dabar, Najafgarh, New Delhi
South West
DELHI |
9205946994
tyagineha9832@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC CBPACS |
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: MEDOROGAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Arjuna kwath, Reference: Bhavpraka sh Madhyam khand vatadi varg, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 40(ml), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 60 Days, anupAna/sahapAna: Yes(details: -Lukewarm water), Additional Information: - | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Arogyavardhini vati, Reference: Ras ratna samuchya visarpa chikitsa, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 60 Days, anupAna/sahapAna: Yes(details: -Lukewarm water), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
21.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1 Diagnosed and confirmed cases of dyslipidemia based on investigation 2 Patients with any one or more Lakshana of Medoroga 3 Patient above 21 and below 60 years of age either sex who will fulfil the criteria of diagnosis 4 Patients willing and able to participate for trial 5 Patients having controlled Diabetes and Hypertension 6 Patients who are ready to give consent with firm home address and contact number which is readily accessible during course of trial
|
|
| ExclusionCriteria |
| Details |
1 Patient not willing for trail 2 Patient with total cholesterol more than 400mg/dl or triglyceride more than 300mg/dl or LDL more than 200mg/dl or HDL less than 20mg/dl 3 Patient with Hypertension more than 160/100 mm hg 4 Patient having illness like uncontrolled Diabetes mellitus tuberculosis carcinoma or major illness like liver and renal disorders 5 Patient having past history of Myocardial infarction unstable angina and congestive cardiac failure 6 Patient below 21 years of age and above 60 yrs of age 7 Patient having hypersensitivity to any trail drug and 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 hematological parameters of dyslipidemia
Total serum cholesterol less than 200mg/dl
Serum Triglycerides less than 150mg/dl
LDL cholesterol level below 100 mg/dl
HDL cholesterol level above 40mg/dl in men and above 50mg/dl in women
VLDL cholesterol level below 30 mg/dl
|
75 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Improvement in symptoms of Medoroga
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="62"
Sample Size from India="62"
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)
|
10/02/2025 |
| 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 Medoroga is when accumulated Meda dhatu blocks Strotasa’s other Dhatu’s are not properly nourished as a result Meda Dhatu further gets increased. The person with Medo Roga will have Kshudra Shwas (breathlessness), Trishna (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 Arjuna kwath and Arogyavardhini vati in management of dyslipidemia. Total number of patients are 62,31 in each group. In group A- Arjuna kwath will be administered at a dose of 40 ml BD with lukewarm water empty stomach in early morning and evening. In group B- Arogyavardhini vati will be administered at a dose of 500 mg BD with lukewarm water empty stomach in early morning and evening. The design of study is a single centered open-labelled, Randomized, comparative, interventional study |