| CTRI Number |
CTRI/2026/02/102794 [Registered on: 02/02/2026] Trial Registered Prospectively |
| Last Modified On: |
28/01/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Preventive |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Use of Lotion of Rhinacanthus nasutus,a medicinal plant, in skin itch (Scabies) |
|
Scientific Title of Study
|
A Preclinical and Clinical Study to evaluate the efficacy of lotion composed of Rhinacanthus nasutus Linn. Kurz in patients suffering from Pama kustha w.s.r. to Scabies |
| 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 Suresh Kumar Jaiswara |
| Designation |
Reader Department of Dravyaguna Vijnana |
| Affiliation |
Institute of Post Graduate Ayurvedic Education and Research at SVSP Hospital |
| Address |
Dept. of Dravyaguna Vijnana, Room no-T11, Institute of Post Graduate Ayurvedic Education and Research at SVSP Hospital, 294/3/1 A.P.C.Road, Kolkata, West Bengal-700009
Kolkata
WEST BENGAL
700009
India |
| Phone |
9681098261 |
| Fax |
|
| Email |
dr.sureshkjaiswara@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Suresh Kumar Jaiswara |
| Designation |
Reader Department of Dravyaguna Vijnana |
| Affiliation |
Institute of Post Graduate Ayurvedic Education and Research at SVSP Hospital |
| Address |
Dept. of Dravyaguna Vijnana, Room no-T11, Institute of Post Graduate Ayurvedic Education and Research at SVSP Hospital, 294/3/1 A.P.C.Road, Kolkata, West Bengal-700009
Kolkata
WEST BENGAL
700009
India |
| Phone |
9681098261 |
| Fax |
|
| Email |
dr.sureshkjaiswara@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Rajendra Jana |
| Designation |
Post graduate trainee |
| Affiliation |
Institute of Post Graduate Ayurvedic Education and Research at SVSP Hospital |
| Address |
Dept. of Dravyaguna Vijnana, Institute of Post Graduate Ayurvedic Education and Research at SVSP Hospital, 294/3/1 A.P.C.Road, Kolkata, West Bengal-700009
Kolkata
WEST BENGAL
700009
India |
| Phone |
8777365689 |
| Fax |
|
| Email |
rajendra160299@gmail.com |
|
|
Source of Monetary or Material Support
|
| Institute of Post Graduate Ayurvedic Education and Research at SVSP, Govt. of West Bengal, 294/3/1, A.P.C. Road, Kolkata-700009 |
|
|
Primary Sponsor
|
| Name |
Institute of Post Graduate Ayurvedic Education & Research |
| Address |
294/3/1 A.P.C. Road, Kolkata-700009 |
| 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 Suresh Kumar Jaiswara |
Institute of Post Graduate Ayurvedic Education and Research at SVSP Hospital |
Dept. of Dravyaguna Vijnana, Room no-T11, Institute of Post Graduate Ayurvedic Education and Research at SVSP Hospital, 294/3/1 A.P.C.Road, Kolkata, West Bengal-700009
Kolkata
WEST BENGAL |
9681098261
dr.sureshkjaiswara@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICAL COMMITTEE, IPGAE&R AT SVSP |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:L54||Erythema in diseases classified elsewhere. Ayurveda Condition: PAMA(KACCU), |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Other than Classical | | (1) Medicine Name: Lotion prepared from Rhinacanthus nasutus, Reference: NA, Route: Topical, Dosage Form: Malahara/ Ointment/ Balm, Dose: 10(ml), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 7 Days, anupAna/sahapAna: No, Additional Information: Lotion will be prepared from the hydroalchoholic extract of Rhinacanthus nasutus and patient will be advised to apply topically in quantity sufficient. |
|
|
|
Inclusion Criteria
|
| Age From |
5.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. All diagnosed cases of Pama kustha/scabies, irrespective of caste, religion, sex or socio-economic status.
2. Age - 5 years to 60 years
|
|
| ExclusionCriteria |
| Details |
1. Patients suffering from any other systemic disorders such as skin tuberculosis, leprosy etc.
2. Patients suffering from other types of kustha roga.
3.Scabies/Pama kustha with immunodeficiency disorders.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.To determine the efficacy of the extracts of whole plant of Rhinacanthus nasutus Linn. Kurz as anti-scabies agent.
|
1.Literature review, collection of samples, pharmacognosy-2 months
2.Phytochemical study-2 months
3.Preparation of the test drug, experimental Study-3 months
4. Clinical study-8 months
5.Statistical analysis and compilation-3 months
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Effectiveness in reducing the secondary symptoms of scabies like- itching and skin inflammation.
2.Providing evidences supporting its use as a safe, accessible and cost-effective treatment for scabies.
3.Laying out the groundwork for further pharmacological development or clinical trials about Rhinacanthus nasutus Linn. Kurz for future researchers.
|
1.Literature review, collection of samples, pharmacognosy-2 months
2.Phytochemical study-2 months
3.Preparation of the test drug, experimental Study-3 months
4. Clinical study-8 months
5.Statistical analysis and compilation-3 months
|
|
|
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/ Phase 3 |
|
Date of First Enrollment (India)
|
06/08/2026 |
| 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
|
The single arm single blind interventional prospective clinical study of will be carried out at the OPD of the hospital at the Institute of Post Graduate Ayurveda Education & Research at S.V.S.P. Hospital, Government of West Bengal, and Kolkata-700009.The purpose of the study is to evaluate the efficacy of extract obtained from whole plant of Rhinacanthus nasutus Linn. Kurz and made into lotion form for the management of Pama through preclinical and clinical studies. The primary outcome is determining the efficacy of the extracts of whole plant of Rhinacanthus nasutus Linn. Kurz as anti-scabies agent. The ssecondary outcome is to determine the effectiveness in reducing the secondary symptoms of scabies like- itching and skin inflammation, providing evidence supporting its use as a safe, accessible and cost-effective treatment for scabies and laying out the groundwork for further pharmacological development or clinical trials about Rhinacanthus nasutus Linn. Kurz for future researchers. |