| CTRI Number |
CTRI/2025/09/095091 [Registered on: 19/09/2025] Trial Registered Prospectively |
| Last Modified On: |
17/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Other (Specify) |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Compare The Effect Of Pamahara Malhara And Pamari Oil In The Management Of Pama (Scabies) In Children |
|
Scientific Title of Study
|
A Randomized Open Label Comparative Clinical Study To Evaluate The Efficacy Of Pamahara Malhara And Pamari Oil For Local Application In The Management Of Pama(Scabies) In Children |
| 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 Kiran |
| Designation |
PG Scholar |
| Affiliation |
Institute for Ayurved Studies and Research Former Shri Krishna Govt. Ayurvedic College |
| Address |
Department of Kaumarbhritya Institute for Ayurved Studies and
Research Umri Road Sector 8 Kurukshetra 136118
Kurukshetra
HARYANA
136118
India
Kurukshetra
HARYANA
136118
India |
| Phone |
8295147461 |
| Fax |
|
| Email |
kiranlohan7206@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sudhir Malik |
| Designation |
Associate Professor PG Dept. Of Kaumarbhritya |
| Affiliation |
Institute for Ayurved Studies and Research Former Shri Krishna Govt. Ayurvedic College |
| Address |
Department of Kaumarbhritya Institute for Ayurved Studies and
Research Umri Road Sector 8 Kurukshetra 136118
Kurukshetra
HARYANA
136118
India
Kurukshetra
HARYANA
136118
India |
| Phone |
8708383582 |
| Fax |
|
| Email |
drsudhirmalik23@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Kiran |
| Designation |
PG Scholar |
| Affiliation |
Institute for Ayurved Studies and Research Former Shri Krishna Govt. Ayurvedic College |
| Address |
Department of Kaumarbhritya Institute for Ayurved Studies and
Research Umri Road Sector 8 Kurukshetra 136118
Kurukshetra
HARYANA
136118
India
Kurukshetra
HARYANA
136118
India |
| Phone |
8295147461 |
| Fax |
|
| Email |
kiranlohan7206@gmail.com |
|
|
Source of Monetary or Material Support
|
| Institute for Ayurved Studies and Research Former Shri Krishna Government Ayurvedic College
and Hospital Shri Krishna AYUSH University Umri Road Sector 8 Kurukshetra 136118 India |
|
|
Primary Sponsor
|
| Name |
Institute for Ayurved Studies and Research |
| Address |
Institute for Ayurved Studies and Research Former Shri Krishna
Government Ayurvedic College and Hospital Shri Krishna AYUSH
University Umri Road Sector 8 Kurukshetra 136118 |
| Type of Sponsor |
Government medical college |
|
|
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 Kiran |
Institute for Ayurved Studies and Research |
PG Department of
Kaumarbhritya Institute
for Ayurved Studies and
Research Former Shri
Krishna Government
Ayurvedic College and
Hospital Umri Road
Sector 8 Kurukshetra
136118
Kurukshetra
HARYANA
Hisar
HARYANA |
8295147461
kiranlohan7206@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Shri Krishna Ayush University IEC |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:B86||Scabies. Ayurveda Condition: PAMA(KACCU), (2) ICD-10 Condition:B86||Scabies. Ayurveda Condition: PAMA(KACCU), |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Pamari Oil, Reference: Hypotheyical Drug, Route: Topical, Dosage Form: Malahara/ Ointment/ Balm, Dose: 60(ml), Frequency: bd, Bhaishajya Kal: Muhurmuhu, Duration: 15 Days, anupAna/sahapAna: No, Additional Information: -For External Local Application As Per Spread Of Diseases | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Pamahara Malhara, Reference: Rastantra Sara Evam Sidhaparyoga Sangraha- Davitya Khanda 40/237, Route: Topical, Dosage Form: Malahara/ Ointment/ Balm, Dose: 60(g), Frequency: bd, Bhaishajya Kal: Muhurmuhu, Duration: 15 Days, anupAna/sahapAna: No, Additional Information: -For External Local Application As Per Spread Of Diseases |
|
|
|
Inclusion Criteria
|
| Age From |
2.00 Year(s) |
| Age To |
14.00 Year(s) |
| Gender |
Both |
| Details |
Patients With Symptoms Of Pama.
Patient Between Age Group Of 2 Year To 14 Year Irrespective Of Sex, Caste And Religion.
Parents Of Children Willing To Participate In The Research Trial.
|
|
| ExclusionCriteria |
| Details |
Patients In Age Below 2 Year And Above 14 Years.
Patient With Chronic Infection Of Pama I.E. More Than 1 Year.
Patient With Other Skin Diseases Along With Open Wound.
Norwegian And Crusted Scabies.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reduction in clinical signs and symptomps including itching burrows burning sensation and discharge assessed through subjective and objective criteria |
15 Days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Devoloped patient & parents awareness about
faulty dietary habits |
5th day 10th day 15th day |
|
|
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 2/ Phase 3 |
|
Date of First Enrollment (India)
|
01/12/2025 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
A randomized clinical trial has been designed to assess the efficacy of Pamahara Malhara and Pamari Oil for local application in the management of Pama in children of age group 2 year to 14 year is selected from O.P.D of Kaumarbhritya Department of Institute for Ayurveda Studies and Research |