| CTRI Number |
CTRI/2025/12/099267 [Registered on: 16/12/2025] Trial Registered Prospectively |
| Last Modified On: |
15/12/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
To study the effect of Vidanga capsules in high cholesterol condition |
|
Scientific Title of Study
|
To study the efficacy of Vidanga extract capsules in dyslipidaemia w.s.r. to Shonitabhishyanda- A double blind randomized controlled 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 Sowmya Bhat |
| Designation |
Assistant Professor |
| Affiliation |
SDM College of Ayurveda Hospital and Research Centre Kuthpady Udupi |
| Address |
1-81, Shri Sadana Durga post and village Durga Karkala taluk
Department of Swasthavritta and Yoga, SDM College of Ayurveda Hospital and Research Centre Udupi 574118
Udupi
KARNATAKA
576117
India |
| Phone |
9900846287 |
| Fax |
|
| Email |
sapre.soumya@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sowmya Bhat |
| Designation |
Assistant Professor |
| Affiliation |
SDM College of Ayurveda Hospital and Research Centre Kuthpady Udupi |
| Address |
1-81 Shri Sadana Durga post and village Durga Karkala taluk
Department of Swasthavritta and Yoga SDM College of Ayurveda Hospital and Research Centre Udupi 574118
Udupi
KARNATAKA
576117
India |
| Phone |
9900846287 |
| Fax |
|
| Email |
sapre.soumya@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sowmya Bhat |
| Designation |
Assistant Professor |
| Affiliation |
SDM College of Ayurveda Hospital and Research Centre Kuthpady Udupi |
| Address |
1-81 Shri Sadana Durga post and village Durga Karkala taluk
Department of Swasthavritta and Yoga SDM College of Ayurveda Hospital and Research Centre Udupi 574118
Udupi
KARNATAKA
576117
India |
| Phone |
9900846287 |
| Fax |
|
| Email |
sapre.soumya@gmail.com |
|
|
Source of Monetary or Material Support
|
| Infrastructural support is from SDM College of Ayurveda Hospital and Research Centre Udupi |
|
|
Primary Sponsor
|
| Name |
Dr Sowmya Bhat |
| Address |
1-81 Shri Sadana Durga post and village Durga Karkala taluk 576117 |
| Type of Sponsor |
Other [Self sponsored ] |
|
|
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 Sowmya Bhat |
Udupi |
Department Swasthyarakshana and Kayachikitsa OPD number 8 SDM Hospital of Ayurveda Udupi
Udupi
KARNATAKA |
9900846287
sapre.soumya@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| IEC1 SDM Centre For Research in Ayurveda and Allied Sciences |
Approved |
| SDM Centre for Research in Ayurveda and allied sciences |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:E65-E68||Overweight, obesity and other hyperalimentation. Ayurveda Condition: MEDOROGAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Drug | Other than Classical | | (1) Medicine Name: Vrikshamla capsule, Reference: NA, Route: Oral, Dosage Form: Capsules, Dose: 250(mg), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 2 Months, anupAna/sahapAna: Yes(details: Warm water), Additional Information: - | | 2 | Comparator Arm | Drug | Other than Classical | | (1) Medicine Name: Vidanga extract capsules, Reference: NA, Route: Oral, Dosage Form: Capsules, Dose: 250(mg), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 2 Months, anupAna/sahapAna: Yes(details: warm water), Additional Information: test drug |
|
|
|
Inclusion Criteria
|
| Age From |
35.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Individuals diagnosed with dyslipidaemia
Age group 35 to 60 years of age
Subjects willing to give written consent
|
|
| ExclusionCriteria |
| Details |
Hypertension
Diabetes mellitus
Hypothyroidism
Pregnancy and lactation
Other systemic illnesses and addictions |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Pharmacy-controlled Randomization |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
To study the efficacy of Vidanga extract in
dyslipidaemia |
2 months
sample size 40 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Secondary Objectives:
a) To study the efficacy of Vidanga extract on anthropometric parameters
b) To study the efficacy of Vidanga extract on quality of life |
Duration of study: 2 months |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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 1/ Phase 2 |
|
Date of First Enrollment (India)
|
29/12/2025 |
| 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="3"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Open to Recruitment |
| 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
|
Above trial will be conducted in an Ayurveda hospital of Udupi to study the effect of Vidanga extract capsules in dyslipidaemia which is a randomized double blinded controlled clinical trial Aqueous extract of Vidanga is taken for the purpose of study Vidanga is a choice of drug mentioned under sthoulya chikitsa in Charaka Samhita Subjective and Objective Parameters will be studied |