| CTRI Number |
CTRI/2021/12/038565 [Registered on: 10/12/2021] Trial Registered Prospectively |
| Last Modified On: |
08/09/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Effect of Arka Manahshila Taila on Pama (Scabies). |
|
Scientific Title of Study
|
A Pharmaceutico-analytical Study of Arka Manahshila Taila and its Effects on Pama. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Suman |
| Designation |
MD Scholar |
| Affiliation |
Government Ayurvedic College Patna |
| Address |
PG Department of Rasa Shastra and Bhaishajya Kalpana
Government Ayurvedic College
Patna Kadamkuan Bihar
Patna
BIHAR
800003
India |
| Phone |
9102240303 |
| Fax |
|
| Email |
dr.choudhary777suman@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sumeshwar Singh |
| Designation |
Professor and HOD |
| Affiliation |
Government Ayurvedic College Patna |
| Address |
Department of Rasa Shastra and Bhaishajya Kalpana
Government Ayurvedic College Patna Kadamkuan Bihar
Patna
BIHAR
800003
India |
| Phone |
9431881708 |
| Fax |
|
| Email |
sumeshwarsingh.1959@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sumeshwar Singh |
| Designation |
Professor and HOD |
| Affiliation |
Government Ayurvedic College Patna |
| Address |
Department of Rasa Shastra and Bhaishajya Kalpana
Government Ayurvedic College Patna Kadamkuan Bihar
BIHAR
800003
India |
| Phone |
9431881708 |
| Fax |
|
| Email |
sumeshwarsingh.1959@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government Ayurvedic College Patna |
|
|
Primary Sponsor
|
| Name |
Government Ayurvedic College Patna |
| Address |
Government Ayurvedic College and Hospital Patna Kadamkuan Bihar |
| 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 Suman |
Government Ayurvedic College Hospital |
OPD Room No: 10
Department of Rasa Shastra and Bhaishajya Kalpana
Government Ayurvedic College and Hospital Patna Kadamkuan Bihar 800003
Patna
BIHAR |
9102240303
dr.choudhary777suman@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:L00-L99||Diseases of the skin and subcutaneous tissue. Ayurveda Condition: PAMAÂ (KACCU), |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Arka Manahshila, Reference: Chakradatta 50/159, Route: Topical, Dosage Form: Taila, Dose: 5(ml), Frequency: bd, Bhaishajya Kal: Antarabhakta, Duration: 90 Days, anupAna/sahapAna: No, Additional Information: |
|
|
|
Inclusion Criteria
|
| Age From |
10.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patient willing for trial
On the basis of symptoms seen in PAMA like kandu piddika srava rukshta daha etc
|
|
| ExclusionCriteria |
| Details |
PAMA with associated complication
Patients suffering from chronic disease like AIDS cancer T.B and cardiac complication |
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| Improvement in symptoms of scabies |
90 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Improvement in symptoms of scabies |
90 days |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="29" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
01/01/2022 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
In ayurvedic texts pama has been counted in kshudra kushta . pama is considered as predominent in kaph and pitta dosha . It is one of the skin disease according to ayurvedic text in which severe itching is the main symptoms and other symptoms are small pidikka with burning tendency, srava ,kandu,pain Arka manahshila taila selected for assessment in PAMA disease is a herbo mineral formulation mentioned in chakrapani rachit text chakradutta in chapter kustha chikitsa prakaran |