| CTRI Number |
CTRI/2023/05/052843 [Registered on: 18/05/2023] Trial Registered Prospectively |
| Last Modified On: |
22/04/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Effectiveness Of Majishthadi Taila In Pama |
|
Scientific Title of Study
|
To Evaluate The Efficacy Of Manjishthadi Taila In Pama,W.S.R. To Resistant Scabies |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Bharti Painkra |
| Designation |
pg scholar |
| Affiliation |
shri Narayan Prasad Awasthi Government Ayurvedic College Raipur Chhattisgarh |
| Address |
Department of kaumarabhritya,shri Narayan Prasad Awasthi Government Ayurvedic College Raipur Chhattisgarh
Raipur
CHHATTISGARH
492010
India |
| Phone |
7746041754 |
| Fax |
|
| Email |
bhartipainkra700@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Lowkesh Chandravanshi |
| Designation |
Lecturer |
| Affiliation |
shri Narayan Prasad Awasthi Government Ayurvedic College Raipur Chhattisgarh |
| Address |
Department of kaumarabhritya,shri Narayan Prasad Awasthi Government Ayurvedic College Raipur Chhattisgarh
Raipur
CHHATTISGARH
492010
India |
| Phone |
9827822231 |
| Fax |
|
| Email |
lowkeshc@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Lowkesh Chandravanshi |
| Designation |
Lecturer |
| Affiliation |
shri Narayan Prasad Awasthi Government Ayurvedic College Raipur Chhattisgarh |
| Address |
Department of kaumarabhritya,shri Narayan Prasad Awasthi Government Ayurvedic College Raipur Chhattisgarh
Raipur
CHHATTISGARH
492010
India |
| Phone |
9827822231 |
| Fax |
|
| Email |
lowkeshc@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of kaumarabhritya,shri Narayan Prasad Awasthi Government Ayurvedic College Raipur Chhattisgarh 492010 |
|
|
Primary Sponsor
|
| Name |
Department of kaumarabhritya,shri Narayan Prasad Awasthi Govt. Ayurveda Colege Raipur C.G. 492010 |
| Address |
Shri Narayan Prasad Awasthi Govt Ayurveda College Raipur C.G. 492010 |
| 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 Bharti Painkra |
Shri Khudadad Dungaji Government Ayurveda Hospital |
Department of kaumarabhritya OPD No 7 and IPD patient Shri Khudadad Dungaji Government Ayurved Hospital Raipur Chhattisgarh
Raipur
CHHATTISGARH |
7746041754
bhartipainkra700@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| OFFICE OF THE PRINCIPAL , SHRI NARAYAN PRASAD AWASTHI GOVERNMENT AYURVED COLLEGE RAIPUR CHHATTISGARH 492010 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
, , (1) ICD-10 Condition:L089||Local infection of the skin and subcutaneous tissue, unspecified. Ayurveda Condition: clinical menifestation of pama ,more then 1 week, (2) ICD-10 Condition:L089||Local infection of the skin and subcutaneous tissue, unspecified. Ayurveda Condition: clinical menifestation of pama ,more then 1 week, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Manjishthadi taila, Reference: -Yog Ratnakar/uttarardha/kushtha chikitsa/shloka 1, Route: Topical, Dosage Form: Taila, Dose: 15(ml), Frequency: bd, Bhaishajya Kal: , Duration: , anupAna/sahapAna: No, Additional Information: (2) Medicine Name: 30 Days, Reference: No, Route: -, Dosage Form: Taila, Dose: (), Frequency: , Bhaishajya Kal: , Duration: , anupAna/sahapAna: No, Additional Information: | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Manjishthadi taila, Reference: yoga ratnakar, Route: Topical, Dosage Form: Taila, Dose: 2(ml), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 15 Days, anupAna/sahapAna: No, Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
4.00 Year(s) |
| Age To |
16.00 Year(s) |
| Gender |
Both |
| Details |
1.age group 4 to 16 years.
2.patient with clinical menifestation of pama.
3.patient who already taken modern medicine.
4.patient with recurrent pama(scabies).
5.gender both male and female.
6.willing and able to participate for the study duration of 30 days. |
|
| ExclusionCriteria |
| Details |
1.A patient below 4years and above 16years.
2.Systemic illness like heart,renal,respiratory and hepatic disease.
3.The patient on long term medication.
4.Acute case of scabies (within 7 days) |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.itching sensation reduced.
2.redness reduced.
3.papule disapear. |
1.itching sensation reduced within 1 week.
2.redness reduced at within 5 days
3.papule disapear. within 2 weeks. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.kandu daha nasha
2.twak prasadanam.
3.pidika uttpatti kshaya. |
15 days of trial |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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 |
|
Date of First Enrollment (India)
|
20/12/2023 |
| 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
|
nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Pama (scabies) is a contagious disease characterized by shyava ,aruna pidika associated with itching and burning sensation . it rapidly spread from person to person ,especially with poor hygien,the younger children are most at risk.in ayurveda classic Acharya Yog Ratnakar has prescribed Manjishthadi Taila in the management of kushtha roga(Pama). present study is aimed to evaluate the efficacy of manjishthadi taila in pama (resistant scabies).the drug will be advised for local application according to affected area.the duration of study will be 30days (15 days for drug administration and 15 days post follow up).assessment will be done on the basis of subjective and objective criteria adopted for this study. |