| CTRI Number |
CTRI/2026/02/103935 [Registered on: 16/02/2026] Trial Registered Prospectively |
| Last Modified On: |
16/02/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
An ayurvedic study on managing high cholesterol using Amrutadya guggulu and Trayushanadi lauha |
|
Scientific Title of Study
|
Efficacy of Trayushanadi lauha and Amrutadya guggulu in the management of Dyslipidemia- A Randomized Clinical 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 B L Sampritha |
| Designation |
PG Scholar Department of Kayachikitsa |
| Affiliation |
Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital |
| Address |
Kayachikitsa General OPD 2
Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital Tanniruhalla BM Road Hassan Karnataka
Hassan
KARNATAKA
573201
India |
| Phone |
9686922191 |
| Fax |
|
| Email |
samprithabl@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Muttappa Totad |
| Designation |
Professor and HOD |
| Affiliation |
Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital |
| Address |
Kayachikita General OPD 2
Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital Tanniruhalla BM Road Hassan Karnataka
Hassan
KARNATAKA
573201
India |
| Phone |
9886924949 |
| Fax |
|
| Email |
drtotadmuttappa@sdmcahhassan.org |
|
Details of Contact Person
Public Query
|
| Name |
Dr Muttappa Totad |
| Designation |
Professor and HOD |
| Affiliation |
Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital |
| Address |
Kayachikitsa General OPD 2
Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital Tanniruhalla BM Road Hassan Karnataka
KARNATAKA
573201
India |
| Phone |
9886924949 |
| Fax |
|
| Email |
drtotadmuttappa@sdmcahhassan.org |
|
|
Source of Monetary or Material Support
|
| SDM College of Ayurveda and Hospital Hassan Karnataka 573201 India |
|
|
Primary Sponsor
|
| Name |
Dr B L Sampritha |
| Address |
2nd Year PG Scholar Department of Kayachikitsa Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital Tanniruhalla BM Road Hassan 573201 Karnataka |
| 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 |
| B L Sampritha |
Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital |
Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital Tanniruhalla BM Road Hassan Karnataka
Hassan
KARNATAKA |
9686922191
samprithabl@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital Hassan |
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 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Amrutadya Guggulu, Reference: Bhaishajya Ratnavali, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: Warm water), Additional Information: - | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Trayushanadi Lauha, Reference: Bhaishajya Ratnavali, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: Warm water), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1 Patients diagnosed to have dyslipidemia as per the diagnostic criteria
2 Patients between age group 30 to 70 years
3 Patients belonging to either gender irrespective of socioeconomic status and caste
4 Subjects willing to participate in the study and ready to sign informed consent form |
|
| ExclusionCriteria |
| Details |
1 Patients who have received anti dyslipidemic medication within last 8 weeks
2 Known cases of dyslipidemia due to endocrine pathologies renal pathologies
3 Dyslipidemia due to drugs eg glucocorticoids
4 Known cases of uncontrolled hypertension diabetes mellitus
5 Known cases of impaired hepatic and cardiac function 6 Pregnant women
7 Lactating mothers |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Primary outcome measure
Lipid profile parameters
Total Cholesterol
Low-Density Lipoprotein
High-Density Lipoprotein
Triglycerides
Secondary outcome measure
Symptoms of medoroga |
Baseline
31st day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1 Quality of Life (Short Form Health Survey SF-36)
2 To observe record and analyze any Adverse Drug Reactions (ADRs) or side effects occurring during the course of the study |
Baseline
4th week |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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 |
|
Date of First Enrollment (India)
|
01/03/2026 |
| 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 - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Clinical Study Report
- Who will be able to view these files?
Response - Researchers who provide a methodologically sound proposal.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [samprithabl@gmail.com].
- For how long will this data be available start date provided 01-01-2028 and end date provided 01-01-2038?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
The present study is an open label double arm randomized comparative clinical trial designed to evaluate the efficacy of Trayushanadi Lauha and Amrutadya Guggulu in the management of Dyslipidemia which is correlated with Medoroga in Ayurveda Dyslipidemia is a major modifiable risk factor for cardiovascular diseases and is increasingly prevalent in both urban and rural populations In Ayurvedic parlance Medoroga arises due to Medovrddhi and Srotorodha leading to impaired nourishment of other Dhatus and manifestation of systemic symptoms A total of 40 subjects diagnosed with dyslipidemia as per National Cholesterol Education Program NCEP guidelines and classical features of Medoroga aged between 30 and 70 years will be randomly allocated into two groups of 20 each Group I intervention group will receive Trayushanadi Lauha 500 mg two tablets twice daily before food with warm water while Group II control group will receive Amrutadya Guggulu 500 mg two tablets twice daily before food with warm water The duration of treatment will be 30 days Assessment will be carried out before and after treatment using lipid profile parameters such as Total Cholesterol LDL C HDL C and Triglycerides as primary outcome measures Secondary outcome measures include assessment of clinical symptoms of Medoroga and evaluation of quality of life using the SF 36 questionnaire Safety will be monitored by recording any adverse drug reactions during the study period Statistical analysis will be performed using repeated measures ANOVA and one way ANOVA for primary outcomes while Friedman test and Kruskal Wallis test will be applied for secondary outcomes The study aims to compare and establish the relative efficacy of Trayushanadi Lauha and Amrutadya Guggulu and to provide scientific evidence for effective safe and economical Ayurvedic management of dyslipidemia |