| CTRI Number |
CTRI/2025/08/093931 [Registered on: 29/08/2025] Trial Registered Prospectively |
| Last Modified On: |
28/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A clinical study to know the effect of Ayurvedic Panchkarma procedure - Sansran Karma inn children with skin disease Eczema (Vicharchika) |
|
Scientific Title of Study
|
A Randomized Open-Labelled Clinical Study To Evaluate The Role Of Sansran Karma In Vicharchika W.S.R. To Eczema In Children |
| Trial Acronym |
nill |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr. Kailash Chandra Kataria |
| Designation |
Assistant proffesor |
| Affiliation |
Government Ayurveda College, Bikaner |
| Address |
kaumarbhritya Department, Room No.04, Government Ayurveda college and Hospital, Bikaner (Rajasthan)
Bandra Bas Mode, Near gogagate circle, Bikaner
Bikaner
RAJASTHAN
334001
India |
| Phone |
7737396206 |
| Fax |
|
| Email |
kailash.kataria07@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Kailash Chandra Kataria |
| Designation |
Assistant proffesor |
| Affiliation |
Government Ayurveda College, Bikaner |
| Address |
Kaumarbhritya Department, Room No. 04, Government Ayurveda College and Hospital, Bikaner (Rajasthan)
Bandra Bas Mode, Near gogagate circle, Bikaner
Bikaner
RAJASTHAN
334001
India |
| Phone |
7737396206 |
| Fax |
|
| Email |
kailash.kataria07@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Suhas A Chaudhary |
| Designation |
Research Officer |
| Affiliation |
M.S. Regional Ayurveda Research Institute, Jaipur |
| Address |
Room no. 11-B, first floor, M.S. Regional Ayurveda Research Institute, Indira Colony, Jhotwara Road, Banipark, Jaipur
Central Council for Research in Ayurvedic Sciences (CCRAS),
Ministry of AYUSH, Govt. of India,Indira Colony, Jhotwara Road,
Bani Park, Jaipur.
Jaipur
RAJASTHAN
302016
India |
| Phone |
9427073351 |
| Fax |
|
| Email |
vdsuhaschaudhary@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
MS Regional Ayurveda Research Institute Jaipur |
| Address |
MS Regional Ayurveda Research Institute (MSRARI),
Central Council for Research in Ayurvedic Sciences (CCRAS),
Ministry of AYUSH, Govt. of India,Indira Colony, Jhotwara Road, Banipark, Jaipur (Rajasthan)
pin code -302016 |
| Type of Sponsor |
Research institution |
|
|
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 Kailash Chandra Kataria |
Government Ayurveda College and Hospital, Bikaner |
Kaumarbhritya Departmental OPD, Room no.04, Govt.Ayurveda Hospital, Bikaner, Bandra bas mod, near gogagate circle, Bikaner
Bikaner
RAJASTHAN |
7737396206
-
kailash.kataria07@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Istitutional Ethical Committee of MS Regional Ayurveda Research Institute Jaipur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:L209||Atopic dermatitis, unspecified. Ayurveda Condition: VICARCIKA, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Procedure | - | Sansran Karma | (Procedure Reference: charaka Samhita Kalpsthan ch.08/08, Procedure details: first 5 to 7 day Deepan Pachana Krma than 3 to 7 days internal snehpana than 3 days external snehan or swedana Karma after that given drug-Amaltasa Phal Majja for Sansran after that Samsarjan Krama will be followed on the basis of Suddhi lakshan.)
(1) Medicine Name: Haridradi vati, Reference: Ashtanga Hridaya ch.19/42, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/Tablets, Dose: 125(mg), Frequency: bd, Duration: 60 Days(2) Medicine Name: KARVEERADHYA TAILA, Reference: B.R. ch. 54/287, Route: Topical, Dosage Form: Taila, Dose: 5(ml), Frequency: bd, Duration: 60 Days | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: haridradi vati, Reference: Ashtanga Hridaya ch.19/42, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 125(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 60 Days, anupAna/sahapAna: No, Additional Information: -(2) Medicine Name: KARVEERADHYA TAILA, Reference: B.R. ch. 54/287, Route: Topical, Dosage Form: Taila, Dose: 5(ml), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 60 Days, anupAna/sahapAna: No, Additional Information: external application |
|
|
|
Inclusion Criteria
|
| Age From |
8.00 Year(s) |
| Age To |
16.00 Year(s) |
| Gender |
Both |
| Details |
1.Patient with classical signs and symptoms of Vicharchika (Eczema) of either sex.
2.Children between the age group of 08 to 16 years.
3.Patient-Oriented Eczema Measure (Poem) score between 08 to 24.
|
|
| ExclusionCriteria |
| Details |
1.Patients below the age of 08 years and more than 16 years will be excluded.
2.The patient suffers from any another chronic skin disease and immune suppressed systemic disorders.
3.Vicharchika (Eczema) with secondary infections.
4.Patient suffering from any other systemic disorders like tuberculosis, Diabetes, HIV, leprosy, etc.
5.Eczemaleads to complications such as eczematization, secondary streptococcal infection, urticaria, etc.
6.Patient-Oriented Eczema Measure (Poem) score less than 08 and more than 24.
7.Virechana Karma Ayogya (Contraindication of purgation therapy) condition |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Change in the EASI (ECZEMA AREA AND SEVERITY INDEX) score. |
Base line, 15th day, 30th day, 45th day, 60th day, 90th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Change in classical signs and symptoms of Vicharchika.
2.Changes in Hematological parameters for the safety of drugs. |
1.classical signs and symptoms(Base line, 15th day, 30th day, 45th day, 60th day, 90th day).
2.Hematological parameters (Base line and 60th day). |
|
|
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 2/ Phase 3 |
|
Date of First Enrollment (India)
|
10/09/2025 |
| 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="2"
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
|
Vicharchika (Eczema) is a common skin disorder,
particularly in children, characterized by Pidika, Kandu, Srava,
Vaivarnyata, Ruja, Daha, and Rukshata. Sansran Karma will
be done first, and then external application of Karveeradhya
Taila and internal administration of Haridradi Vati in
group A. Sansran Karma, an Ayurvedic treatment procedure, is traditionally
believed to have beneficial effects on skin conditions like Vicharchika. In
group B external application of Karveeradhya Taila and internal administration
of Haridradi Vati will be given. This clinical trial aims to assess
the effectiveness of Sansran Karma in treating Eczema in
children. |