| CTRI Number |
CTRI/2023/09/057184 [Registered on: 01/09/2023] Trial Registered Prospectively |
| Last Modified On: |
29/08/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Unani
Other (Specify) [TREATMENT] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
This study is to observe the effectiveness of unani medicine scientifically in the treatment of scabies |
|
Scientific Title of Study
|
Randomised,Single Blinded clinical trial of unani formulations in the treatment of Jarb(Scabies). |
| Trial Acronym |
NILL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Zamir Ahmad |
| Designation |
Professor |
| Affiliation |
Ajmal Khan Tibbiya College,A.M.U,Aligarh |
| Address |
Chairmans Office,Department Of Amraz E Jild Wa Tazeeniyat,Ajmal Khan Tibbiya College, Aktc,A.M,U,Aligarh,Uttar Pradesh
Near Tasveer Mahal,Besides the Police Control Room,In Front Of Tibbiya Hospital Aligarh,U.P,202002
Aligarh
UTTAR PRADESH
202002
India |
| Phone |
8475007594 |
| Fax |
915712700994 |
| Email |
Drzamiramrohi@Gmail.Com |
|
Details of Contact Person
Scientific Query
|
| Name |
Zamir Ahmad |
| Designation |
Professor |
| Affiliation |
Ajmal Khan Tibbiya College,A.M.U,Aligarh |
| Address |
Chairmans Office,Department Of Amraz E Jild Wa Tazeeniyat,Ajmal Khan Tibbiya College, Aktc,A.M,U,Aligarh,Uttar Pradesh
Near Tasveer Mahal,Besides the Police Control Room,In Front Of Tibbiya Hospital Aligarh,U.P,202002
Aligarh
UTTAR PRADESH
202002
India |
| Phone |
8475007594 |
| Fax |
915712700994 |
| Email |
Drzamiramrohi@Gmail.Com |
|
Details of Contact Person
Public Query
|
| Name |
Zamir Ahmad |
| Designation |
Professor |
| Affiliation |
Ajmal Khan Tibbiya College,A.M.U,Aligarh |
| Address |
Chairmans Office,Department Of Amraz E Jild Wa Tazeeniyat,Ajmal Khan Tibbiya College, Aktc,A.M,U,Aligarh,Uttar Pradesh
Near Tasveer Mahal,Besides the Police Control Room,In Front Of Tibbiya Hospital Aligarh,U.P,202002
Aligarh
UTTAR PRADESH
202002
India |
| Phone |
8475007594 |
| Fax |
915712700994 |
| Email |
Drzamiramrohi@Gmail.Com |
|
|
Source of Monetary or Material Support
|
| Department of Amraz e jild wa Tazeeniyat,Ajmal Khan Tibbiya College,Faculty of Unani Medicine,Aligarh Muslim University,Aligarh |
|
|
Primary Sponsor
|
| Name |
Aligarh Muslim University Aligarh |
| Address |
A.M.U,Campus,Near Bab E Syed ,Aligarh,U.P,202001. |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Prof Zamir Ahmad |
Amraz E Jild Wa Tazeeniyat,Ajmal Khan Tibbiya College,A.M.U,Aligarh |
Ajmal Khan Tibbiya College,
Near Tasveer Mahal,Besides the Police Control Room,In Front Of Tibbiya Hospital Aligarh,U.P,202002
Aligarh
UTTAR PRADESH |
8475007594
915712700994
Drzamiramrohi@Gmail.Com |
| Sumera Sagheer |
Amraz E Jild Wa Tazeeniyat,Ajmal Khan Tibbiya College,A.M.U,Aligarh |
Ajmal Khan Tibbiya College Aligarh,Near Police Control Room,In Front Of Tibbiya Hospital,Aligarh
Aligarh
UTTAR PRADESH |
9997529281
915712700994
ssahmad227@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee,Faculty of Unani Medicine, A.M.U, Aligarh |
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, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Drug A [Gandhak(Sulfur) dissolved in Sirka e Jamun(Indian Blackberry Vinegar)] |
10 grams of Gandhak(Sulfur) dissolved in 100 ml of Sirka e Jamun(Indian Blackberry Vinegar),will be applied once every night locally or topically for 7 days on whole body below neck. |
| Comparator Agent |
Drug B [Kutki(Picrorhiza kurroa)
dissolved in Sirka e Angoori(Grape Vinegar)]. |
10 grams of Kutki (Picrorhiza kurroa) dissolved in 100 ml of Sirka e Angoori(Grape Vinegar),will be applied once every night locally or topically for 7 days on whole body below neck. |
|
|
Inclusion Criteria
|
| Age From |
2.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Patients from 2 years to 70 years of age.
Both Female & Male patients.
Scabies mite positive in direct microscopy with KOH.
Patients with positive family history of itching and papules.
Clinically stable patients.
|
|
| ExclusionCriteria |
| Details |
Patients below 2 years and above 70 years of age.
Pregnant,lactating mothers.
Scabies mite negative in direct microscopy with KOH.
Patient who fail to give consent.
Patient who fail to follow up.
Mentally challenged person.
|
|
|
Method of Generating Random Sequence
|
Stratified randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Patient will be cured. |
7 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Tested Unani drugs will be validated scientifically |
14 months |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
10/09/2023 |
| 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="4"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Publication will be made after completion of the study. |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
THIS STUDY IS PLANNED TO VALIDATE UNANI TREATMENT OF SCABIES SCIENTIFICALLY. IN THIS STUDY TWO DIFFERENT TREATMENT MENTIONED IN UNANI LITERATURE WILL BE COMPARED AS PER RESEARCH PROTOCOL AFTER GETTING CTRI REGISTRATION NUMBER. THE COLLECTED DATA OF THE INFORMATION WILL BE ANALYSED STATISCALLY BY USING APPROPRIATE STATISTICAL METHOD AND TOOLS. |