| CTRI Number |
CTRI/2025/02/080897 [Registered on: 19/02/2025] Trial Registered Prospectively |
| Last Modified On: |
|
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A clinical study on the effect of Varasanadi kashaya 20ml with 10ml honey and 20ml warm water twice a day orally in comparison with Guduchibadhramustadi kashaya 20ml with 30ml warm water twice a day orally in Dyslipidemia in adults of age group 20-60 years for a period of 30 days |
|
Scientific Title of Study
|
To study the efficacy of Varasanadi kashaya in comparison with Guduchibadhramustadi kashaya in Dyslipidemia: A controlled randomized clinical study |
| 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 Deepika S |
| Designation |
Post Graduate Scholar Department of Kayachikitsa |
| Affiliation |
Shri Dharmasthala Manjunatheshwara Institute of Ayurveda and Hospital, Bengaluru. |
| Address |
Department of Kayachikitsa OPD Number 1,2,3,18,27 Shri Dharmasthala Manjunatheshwara Institute of Ayurveda and Hospital, SH 17 Anchepalya, Kumbalagodu post, Bengaluru- 560074, Karnataka, India.
Bangalore
KARNATAKA
560074
India |
| Phone |
07598958847 |
| Fax |
|
| Email |
deepikashan2000@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Srinivasa S |
| Designation |
Professor and Head of Department |
| Affiliation |
Shri Dharmasthala Manjunatheshwara Institute of Ayurveda and Hospital, Bengaluru. |
| Address |
Department of Kayachikitsa OPD Number 2 Shri Dharmasthala Manjunatheshwara Institute of Ayurveda and Hospital, SH 17 Anchepalya, Kumbalagodu post, Bengaluru- 560074, Karnataka, India.
Bangalore
KARNATAKA
560074
India |
| Phone |
09448211053 |
| Fax |
|
| Email |
ssomayaji78@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Deepika S |
| Designation |
Post Graduate Scholar Department of Kayachikitsa |
| Affiliation |
Shri Dharmasthala Manjunatheshwara Institute of Ayurveda and Hospital, Bengaluru. |
| Address |
Department of Kayachikitsa OPD Number 1,2,3,18,27 Shri Dharmasthala Manjunatheshwara Institute of Ayurveda and Hospital, SH 17 Anchepalya, Kumbalagodu post, Bengaluru- 560074, Karnataka, India.
Bangalore
KARNATAKA
560074
India |
| Phone |
07598958847 |
| Fax |
|
| Email |
deepikashan2000@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Kayachikitsa OPD Number 1,2,3,18,27 Shri Dharmasthala Manjunatheshwara Institute of Ayurveda and Hospital, SH 17 Anchepalya, Kumbalagodu post, Bengaluru- 560074, Karnataka, India. |
|
|
Primary Sponsor
|
| Name |
Dr Deepika S |
| Address |
Department of Kayachikitsa OPD Number 1,2,3,18,27 Shri Dharmasthala Manjunatheshwara Institute of Ayurveda and Hospital, SH 17 Anchepalya, Kumbalagodu post, Bengaluru- 560074, Karnataka, India. |
| Type of Sponsor |
Other [Self] |
|
|
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 Deepika S |
Shri Dharmasthala Manjunatheshwara Institute of Ayurveda and Hospital, Bengaluru |
Department of Kayachikitsa OPD Number 1,2,3,18,27 Shri Dharmasthala Manjunatheshwara Institute of Ayurveda and Hospital, SH 17 Anchepalya, Kumbalagodu post, Bengaluru- 560074, Karnataka, India.
Bangalore
KARNATAKA |
07598958847
deepikashan2000@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Shri Dharmasthala Manjunatheshwara Ayurveda and Hospital |
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: Varasanadi Kashaya, Reference: SAHASRAYOGAM KASHAYA YOGA PRAKARANA, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 20(ml), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: 10ml Madhu + 20ml Sukoshna Jala), Additional Information: - | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Guduchibadhramustadi Kashaya, Reference: CHARAKA SAMHITA, SUTRASTHANA, ASTOU NINDITIYA ADHYAYAM, 21st CHAPTER, 22nd SLOKA, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 20(ml), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: 30ml Sukoshna Jala), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Subjects with age group of 20-60 years of either sex irrespective of religion will be selected.
2.Subjects fulfilling all or at least any one of the diagnostic criteria.
3.Fresh cases and patients on medication of dyslipidemia maintaining the manufacturer and batch compulsorily with persisting signs and symptoms and altered quality of life.
|
|
| ExclusionCriteria |
| Details |
1.Subjects belonging to the age group of below 20 and above 60 years.
2.Subjects suffering from Chronic systemic illness like Type 1 DM, uncontrolled Type 2 DM, uncontrolled Hypertension.
3.Pregnant and lactating women.
4.Subjects under corticosteroid medications.
5.Subjects having history of myocardial infarction, stroke.
6.Subjects suffering from pancreatitis, thyroid dysfunction.
|
|
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Method of Generating Random Sequence
|
Computer generated randomization |
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Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
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Primary Outcome
|
| Outcome |
TimePoints |
| Improvement in the lipid profile. |
0th day(Baseline), 30th day and 45th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Improvement in the lakshana of Medo roga. |
0th day(Baseline), 30th day and 45th day |
|
|
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)
|
01/03/2025 |
| 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) |
Open to Recruitment |
|
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
|
A Controlled Clinical Study on the Efficacy of Varasanadi Kashaya in the Management of Dyslipidemia in adults of age group of 20-60 years for a period of 30days.
During this study period, 30 subjects diagnosed with Dyslipidemia will be recruited and divided into two groups,
Group A (Trial drug/Intervention group) and Group B (Control drug/Comparator group), 15 subjects in each group respectively.
Group A (Trial drug/Intervention
group) it includes 15 subjects qualifying inclusion criteria of the current study will be administered Varasanadi Kashaya (50ml BID Before food)
for 30days starting from day-01 of trial, assessment of the patient during trial on 0th day(baseline), 30th day and after trial on 45th day. Group B (Control Drug/Comparator Group) it includes
15 subjects qualifying inclusion criteria of the current study will be administered Guduchibadhramustadi Kashaya (50ml BID Before food) for 30days starting from day-01 of trial, assessment of the patient during trial on 0th day(baseline), 30th day and after trial on 45th day.
Clinical assessment will be done for both subjective and objective criteria on 0th day, 30th
day and after trial 45th day.
Statistical analysis will be done through data obtained on before and after treatment assessment. |