| CTRI Number |
CTRI/2025/09/094799 [Registered on: 15/09/2025] Trial Registered Prospectively |
| Last Modified On: |
15/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
EFFECTIVENESS OF MANIBHADRA LEHA WITH AND WITHOUT PANCHATIKTA GHRITA MATRA BASTI IN PSORIASIS TREATMENT |
|
Scientific Title of Study
|
COMPARATIVE CLINICAL EVALUATION OF MANIBHADRA LEHA WITH AND WITHOUT PANCHATIKTA GHRITA MATRA BASTI IN EKKUSTHA PSORIASIS |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sakshi choudhary |
| Designation |
Post Graduate Scholar |
| Affiliation |
Patanjali Bhartiya Ayurvigyan Evam Anusandhan Sansthan |
| Address |
Patanjali Bhartiya Ayurvigyan Evam Anusandhan Sansthan Delhi Haridwar Highway 58 Haridwar Uttarakhand
Kaumarbhritya deptt, Room no 402, Patanjali Bhartiya Ayurvigyan Evam Anusandhan Sansthan Delhi Haridwar Highway 58 Haridwar Uttarakhand
Hardwar
UTTARANCHAL
249405
India |
| Phone |
7830950521 |
| Fax |
|
| Email |
sakshichoudhary951013@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr priyanka wadhwa |
| Designation |
Associate Professor |
| Affiliation |
Patanjali Bhartiya Ayurvigyan Evam Anusandhan Sansthan |
| Address |
OPD NO 5 Patanjali Bhartiya Ayurvigyan Evam Anusandhan Sansthan Delhi Haridwar Highway 58 Haridwar Uttarakhand
Kaumarbhritya deptt, Room no 402, Patanjali Bhartiya Ayurvigyan Evam Anusandhan Sansthan, Delhi Haridwar Highway 58 Haridwar Uttarakhand
Hardwar
UTTARANCHAL
249405
India |
| Phone |
8105938269 |
| Fax |
|
| Email |
pwadhwa13@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Payal Thakur |
| Designation |
Assistant Professor |
| Affiliation |
Patanjali Bhartiya Ayurvigyan Evam Anusandhan Sansthan |
| Address |
OPD NO 5 Patanjali Bhartiya Ayurvigyan Evam Anusandhan Sansthan, Delhi Haridwar Highway 58 Haridwar, Uttarakhand
Kaumarbhritya deptt, Room no 402, Patanjali Bhartiya Ayurvigyan Evam Anusandhan Sansthan, Delhi Haridwar Highway 58 Haridwar, Uttarakhand
Hardwar
UTTARANCHAL
249405
India |
| Phone |
9568242518 |
| Fax |
|
| Email |
pt3544080@gmail.com |
|
|
Source of Monetary or Material Support
|
| Patanjali Bhartiya Ayurvigyan Evam Anusandhan Sansthan |
|
|
Primary Sponsor
|
| Name |
Patanjali Bhartiya Ayurvigyan Evam Anusandhan |
| Address |
Patanjali Bhartiya Ayurvigyan Evam Anusandhan Delhi Haridwar Highway 58 Haridwar uttarakhand |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| Sakshi choudhary |
Patanjali Bhartiya Ayurvigyan Evam Anusandhan Sansthan |
OPD NO 5 Department of Kaumarbhritya Patanjali Bhartiya Ayurvigyan Evam Anusandhan Sansthan Delhi Haridwar Highway 58 Haridwar Uttarakhand
Patanjali Bhartiya Ayurvigyan Evam Anusandhan Sansthan Delhi Haridwar Highway 58 Haridwar Uttarakhand
Hardwar
UTTARANCHAL |
7830950521
sakshichoudhary951013@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Patanjali Bhartiya Ayurvigyan Evam Anusandhan Sansthan |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:L409||Psoriasis, unspecified. Ayurveda Condition: EKAKUSHTHAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | dIpana, pAcana, aBya~ggaH, mAtrAbastiH svedanam, | (Procedure Reference: Yogaratnakar, Procedure details: dose 24ml-96ml
frequency once a day
duration 7 days
route per anal)
(1) Medicine Name: Manibhadra Leha, Reference: Ashtanga Hridya, Route: Oral, Dosage Form: Avleha/Leha/Paka/Raskriya, Dose: 7(g), Frequency: bd, Duration: 23 Days | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Manibhadra Leha, Reference: Ashtanga hridhay, Route: Oral, Dosage Form: Avleha/Leha/Paka/Raskriya, Dose: 7(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 1 Months, anupAna/sahapAna: Yes(details: -Leukwarm Water), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
5.00 Year(s) |
| Age To |
16.00 Year(s) |
| Gender |
Both |
| Details |
Children aged between 5-16 years
Patients of either sex
Children having classical sign and symptoms of psoriasis
|
|
| ExclusionCriteria |
| Details |
Patients below 5 years of age and above 16 years of age
Patient suffering from any other chronic systemic illness and allergic disorders
Patient diagnosed with any other skin disorder except psoriasis
Patient not fulfilling the inclusion criteria
Patient and attendant not willing to given written consent for participation
Patient with any complication of psoriasis example pustular psoriasis psoriasis with arthritis
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
change in clinical presentation of psoriasis assess through
1. PASI Score
2. CDQLI Score
3. Improvement in subjective parameter like itching,scaling,erythema
4. Change in subjective parameter like Auspitz sign, candle grease sign
|
Base line assessment day0
mid treatment assessment day15
post treatment assessment day45 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Improvement in scar and itching and Improvement in over all health of the patient |
45 days |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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 3 |
|
Date of First Enrollment (India)
|
27/09/2025 |
| 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="2"
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
|
This is an open label, comparative clinical trial to evaluate the efficacy of Manibhadra Leha with and without Panchtikta Ghrita Matra Basti in Psoriasis. A total number of 60 patient fulfilling the inclusion criteria will be randomly divided into 30 each. One group will be recieving Manibhadra Leha for 30 days and other will be recieving Manibhadra Leha for 23 days with Panchtikta Ghrita Matra Basti for 7 days.The efficacy will be assessed based on subjective symptoms like itching, erythema, scaling and PASI score along with CDQLI scale. Follow up will be done on 7th,15th,30th and 45th day of study. The aim is to compare both regimens and provide a cost effective, safe, and efficient ayurvedic intervention for Psoriasis. |