| CTRI Number |
CTRI/2024/10/076012 [Registered on: 29/10/2024] Trial Registered Prospectively |
| Last Modified On: |
28/10/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Clinical Trial On Two Ayurveda Medicines-Tryoshnadi Guggulu And Medohar Guggulu Along With Arjun Kwath In Dyslipidemia |
|
Scientific Title of Study
|
Comparative Clinical Study Of Tryoshnadi Guggulu And Medohar Guggulu Along With Arjun Kwath In 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 Diksha Bahuguna |
| Designation |
Post Graduate Scholar |
| Affiliation |
Patanjali Bhartiya Ayurvigyan Evam Anusandhan Sansthan |
| Address |
OPD-13,Department Of Kayachikitsa, Patanjali Ayurved Hospital, Patanjali Bhartiya Ayurvigyan Evam Anusandhan Sansthan,Phase-1, Roorkee Road, Haridwar, Uttarakhand, India
Hardwar
UTTARANCHAL
249405
India |
| Phone |
7906197036 |
| Fax |
|
| Email |
dikshabahuguna27@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vikram Gupta |
| Designation |
Professor, Department Of Kayachikitsa |
| Affiliation |
Patanjali Bhartiya Ayurvigyan Evam Anusandhan Sansthan |
| Address |
OPD-13,Department Of Kayachikitsa, Patanjali Ayurved Hospital, Patanjali Bhartiya Ayurvigyan Evam Anusandhan Sansthan,Phase-1, Roorkee Road, Haridwar, Uttarakhand, India
Hardwar
UTTARANCHAL
249405
India |
| Phone |
8958640973 |
| Fax |
|
| Email |
vd.vikram20@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Vikram Gupta |
| Designation |
Professor, Department Of Kayachikitsa |
| Affiliation |
Patanjali Bhartiya Ayurvigyan Evam Anusandhan Sansthan |
| Address |
OPD-13,Department Of Kayachikitsa, Patanjali Ayurved Hospital, Patanjali Bhartiya Ayurvigyan Evam Anusandhan Sansthan,Phase-1, Roorkee Road, Haridwar, Uttarakhand, India
Hardwar
UTTARANCHAL
249405
India |
| Phone |
8958640973 |
| Fax |
|
| Email |
vd.vikram20@gmail.com |
|
|
Source of Monetary or Material Support
|
| Patanjali Bhartiya Ayurvigyan Evam Anusandhan Sansthan,Phase-1, Roorkee Road, Haridwar, Uttarakhand, India 249405 |
|
|
Primary Sponsor
|
| Name |
Patanjali Bhartiya Ayurvigyan Evam Anusandhan Sansthan |
| Address |
Patanjali Bhartiya Ayurvigyan Evam Anusandhan Sansthan,Phase-1, Roorkee Road, Haridwar, Uttarakhand, India 249405 |
| Type of Sponsor |
Private 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 |
| Dr Diksha Bahuguna |
Patanjali Bhartiya Ayurvigyan Evam Anusandhan Sansthan |
OPD-13,Department Of Kayachikitsa, Patanjali Ayurved Hospital, Patanjali Bhartiya Ayurvigyan Evam Anusandhan Sansthan,Phase-1, Roorkee Road, Haridwar, Uttarakhand, India
Hardwar
UTTARANCHAL |
7906197036
dikshabahuguna27@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Patanjali Bhartiya Ayurvigyan Evam Anusandhan Sansthan Institutional Ethical Commitee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:E785||Hyperlipidemia, unspecified. Ayurveda Condition: MEDOROGAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Medohar Guggulu, Reference: Krishnagopal. (2023). Rasatantrasara and Siddhapryogsangrah, Krishnagopal Granthmala, Dvitya Ratna and Dvitya Khand - Chapter 30 (p. 190). In MedoharGuggulu., Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 1000(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 90 Days, anupAna/sahapAna: Yes(details: -Arjun Kwath), Additional Information: - | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Tryoshnadi Guggulu, Reference: Bhramshankar Mishra Shastri. Bhavprakash Samhita :Vidyotini commentary Vol 2.by Bhav Mishra, Reprint 2016 Chaukhamba Sanskrit Sansthan, Varanasi.Chapter 39/31 p.413, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 1000(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 90 Days, anupAna/sahapAna: Yes(details: -Arjun Kwath), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
• Patients willing to participate.
• Diagnosed and confirmed cases of Dyslipidemia fulfilling at least one of the following criteria.
Serum Cholesterol greater than 200mg/dl
Serum Triglycerides greater than 150mg/dl
Serum LDL greater than 100mg/dl
Serum VLDL greater than 30mg/dl
Serum HDL less than 40mg/dl |
|
| ExclusionCriteria |
| Details |
• Patients suffering from type 1 diabetes mellitus, uncontrolled diabetes mellitus, uncontrolled hypertension, and uncontrolled hypothyroidism.
• Drug-induced or uncontrolled Dyslipidemia.
• Patient having systemic illness like tuberculosis, carcinoma, and endocrine disorders or major illness like renal or liver disorder.
• Patient with acute myocardial infarction & unstable Angina.
• Patient having clinical features of congestive cardiac failure.
• Pregnant and lactating women. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Objective:
• Lipid profile- serum cholesterol, serum triglycerides, serum HDL, serum LDL, serum VLDL.
• Body weight (in kg) - weighing machine
• Body mass index (BMI) (kg/m2) |
0,30th and 90th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Subjective:
• Chala- Sphika- Udara -Stana
• Kshudra Shwasa
• Sandhi Shoola
• Kshudha Atimatra
• Pipasa Atiyoga
• Nidradhikya
• Javop rodha
• Swedabadha
• Daurgandhya |
90th day |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "60"
Final Enrollment numbers achieved (India)="60" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
08/11/2024 |
| Date of Study Completion (India) |
21/08/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Completed |
|
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
|
This is a comparative clinical evaluation of Tryoshnadi Guggulu and Medohar Guggulu along with Arjun Kwath in Dyslipidemia. This trial will be conducted on 60 randomly selected patients from OPD of Kayachikitsa of Patanjali Bhartiya Ayurvigyan Evam Anusandhan Sansthan, Haridwar. Patients will be divided into 2 groups- 30 patients will be administered Tryoshnadi Guggulu with Arjun Kwath and 30 patients will be administered Medohar Guggulu with Arjun Kwath. First, follow up will be on 30th day of first visit and second follow up will be on 90th day of first visit that is on completion of treatment. Assessment will be done on the basis of subjective and objective parameters mentioned earlier. |