| CTRI Number |
CTRI/2025/07/091626 [Registered on: 24/07/2025] Trial Registered Prospectively |
| Last Modified On: |
23/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparing the effect of an oral ayurvedic medicine with and without ayurvedic powder massage in controlling high cholesterol. |
|
Scientific Title of Study
|
A comparative clinical study to evaluate the efficacy of Ksharadi Lauha with and without Udvartana in the management of Medodusti with special reference to 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 Prachee Rekha Panigrahi |
| Designation |
MD Scholar |
| Affiliation |
Pt Khushilal Sharma Government Autonomous Ayurveda College and Institute |
| Address |
PG Department of Kayachikitsa
Pt Khushilal Sharma Government Autonomous Ayurveda College and Institute
Bhopal
PG Department of Kayachikitsa Pt Khushilal Sharma Government Autonomous Ayurveda College and Institute
Bhopal
Bhopal
MADHYA PRADESH
462003
India |
| Phone |
6371486669 |
| Fax |
|
| Email |
pracheerekhap@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Swati Nagpal |
| Designation |
Reader |
| Affiliation |
Pt Khushilal Sharma Government Autonomous Ayurveda College and Institute |
| Address |
Pt Khushilal Sharma Government Autonomous Ayurveda College and Institute
Bhopal
PG Department of Kayachikitsa
Pt Khushilal Sharma Government Autonomous Ayurveda College and Institute
Bhopal
Bhopal
MADHYA PRADESH
462003
India |
| Phone |
9406970945 |
| Fax |
|
| Email |
nagpalswati460@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Prachee Rekha Panigrahi |
| Designation |
MD Scholar |
| Affiliation |
Pt Khushilal Sharma Government Autonomous Ayurveda College and Institute |
| Address |
PG Department of Kayachikitsa
Pt Khushilal Sharma Government Autonomous Ayurveda College and Institute
Bhopal
PG Department of Kayachikitsa
Pt Khushilal Sharma Government Autonomous Ayurveda College and Institute
Bhopal
Bhopal
MADHYA PRADESH
462003
India |
| Phone |
6371486669 |
| Fax |
|
| Email |
pracheerekhap@gmail.com |
|
|
Source of Monetary or Material Support
|
| Pt Khushilal Sharma Government Autonomous Ayurveda College and Institute
Bhopal Madhyapradesh |
|
|
Primary Sponsor
|
| Name |
Pt Khushilal Sharma Government Autonomous Ayurveda College and Institute Bhopal Madhyapradesh |
| Address |
PG Deparment of Kayachikitsa
Pt Khushilal Sharma Government Autonomous Ayurveda College and Institute Bhopal Madhyapradesh |
| Type of Sponsor |
Government funding agency |
|
|
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 Prachee Rekha Panigrahi |
Pt Khushilal Sharma Government(Autonomous) Ayurveda College and Institute Bhopal(Madhyapradesh) |
Room No. 221
PG Department of Kayachikitsa
Pt Khushilal Sharma Government(Autonomous) Ayurveda College and Institute Bhopal(Madhyapradesh)
Bhopal
MADHYA PRADESH |
6371486669
pracheerekhap@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Pt Khushilal Sharma Government(Autonomous) Ayurveda College and Institution Bhopal(Madhyapradesh) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:E782||Mixed hyperlipidemia. Ayurveda Condition: MEDOVAISHAMYAM, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Drug | Classical | | | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Ksharadi Lauha, Reference: Vishwanath Sen Krit Chikitsa Arnav, Uttararddha, Medorogadhikar, Route: Oral, Dosage Form: Churna/ Powder, Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 45 Days, anupAna/sahapAna: Yes(details: Honey), Additional Information: - | | 3 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Ksharadi Lauha, Reference: Vishwanath Sen Krit Chikitsa Arnav, Uttararddha, Medorogadhikar, Route: Oral, Dosage Form: Churna/ Powder, Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 45 Days, anupAna/sahapAna: Yes(details: -Honey), Additional Information: - | | 4 | Comparator Arm | Procedure | - | udvartanam, उद्वर्तनम् | (Procedure Reference: Sushrut Samhita, Chikitsa sthana, Chapter 24, Procedure details: Udvartanam procedure will be done before bath, in Supine, Prone, Left lateral and right lateral positions, for 30 minutes)
(1) Medicine Name: Triphala Churna, Reference: Bhavaprakash, Haritakyadi Varga, Route: Topical, Dosage Form: Churna/ Powder, Dose: 300(g), Frequency: od, Duration: 21 Days |
|
|
|
Inclusion Criteria
|
| Age From |
21.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients with deranged lipid profile any one or more than one of the following
Total Cholesterol 200 mg per dl to less than 330mg per dl
LDL Cholesterol 100mg per dl to less than 190 mg per dl
Serum Triglycerides 150mg per dl to less than 500 mg per dl
Patients those have given written consent to participate in the study
|
|
| ExclusionCriteria |
| Details |
Patients with previously diagnosed Cardiovascular diseases Cerebrovascular diseases Immunocompromised diseases Diabetes mellitus Hypothyroidism
Patients who are taking Hypolipidemic drugs
Patients who are taking drugs which cause Dyslipidemia like Diuretics Cyclosporins Betablockers Retinoids Glucocorticoids Antiretroviral agents Androgens
Patients with any Skin disease
Lactating and pregnant women
|
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| It is expected that at the end of the study we will be able to demonstrate and explain the efficacy of Ksharadi Lauha with and without Udvartana in the management of Dyslipidemia. |
12 Months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
Nil |
|
|
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)
|
10/08/2025 |
| 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="0"
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
|
It is expected that at the end of the study we will be able to demonstrate and explain the efficacy of Ksharadi Lauha with and without Udvartana in the management of Dyslipidemia |