| CTRI Number |
CTRI/2024/09/074512 [Registered on: 27/09/2024] Trial Registered Prospectively |
| Last Modified On: |
27/09/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Unani |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
safety and efficacay of unani formulation Majoon Mussaffi-Azam in Busoor(skin eruptions). |
|
Scientific Title of Study
|
Clinical validation of Unani pharmacopoeial formulation Majoon Mussaffi Azam in Busoor(Skin eruptions) |
| 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 Huma |
| Designation |
Research officer(unani) |
| Affiliation |
Regional research institute of unani medicine |
| Address |
Clinical department ,Regional research institute of Unani medicine Habak Naseem bagh Srinagar Kashmir
Srinagar
JAMMU & KASHMIR
190007
India |
| Phone |
9796550059 |
| Fax |
|
| Email |
humaccrum@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Huma |
| Designation |
Research officer(unani) |
| Affiliation |
Regional research institute of unani medicine |
| Address |
Clinical department ,Regional research institute of unani medicine Habak naseem bagh srinagar Kashmir
Srinagar
JAMMU & KASHMIR
190007
India |
| Phone |
9796550059 |
| Fax |
|
| Email |
humaccrum@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Huma |
| Designation |
Research officer(unani) |
| Affiliation |
Regional research institute of unani medicine |
| Address |
Clinical departmentRegional research institute of unani medicine Habak naseem bagh srinagar Kashmir
Srinagar
JAMMU & KASHMIR
190007
India |
| Phone |
9796550059 |
| Fax |
|
| Email |
humaccrum@gmail.com |
|
|
Source of Monetary or Material Support
|
| Ministry of Ayush ,Govt of India,Ayush bhawan INA,New Delhi India |
|
|
Primary Sponsor
|
| Name |
central council for research in Unani medicine |
| Address |
61-65,Institutional Area,opposite D block Janakpuri,New Delhi 110058 |
| Type of Sponsor |
Research institution |
|
|
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 Huma |
Regional research institute of Unani medicine |
Clinical department, Regional research institute of Unani medicne ,Habak Naseem bagh Srinagar
Srinagar
JAMMU & KASHMIR |
9796550059
humaccrum@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: L709||Acne, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Majoon-musaffi-e-Azam |
It is a semisolid preparation and is to be given orally 7gms twice daily for 6 weeks |
|
|
Inclusion Criteria
|
| Age From |
12.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Female |
| Details |
Frequently occurrence of Busoor, with or without association of following features.
1.Humra (Erythema)
2 .Waja (Pain)
3. Hikka (Itching
|
|
| ExclusionCriteria |
| Details |
1 .Patients of Busoor associated with fever.
2. Patients with other inflammatory and suppurated conditions of skin e.g. Abscess, Carbuncle, and Cellulitis.
3.Patients with features of Cellulitis
4.Patients with diabetes mellitus
5.Patients with disease required long term treatment e.g. Metabolic Disorders, specific infectious disease and cancer etc.
6.Pregnancy and lactation
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The lesion will be evaluated according to its number, size, and associated symptoms. Grading on the basis of the number of lesions will be recorded |
Baseline,Day 7,Day 14,Day 28 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
nil |
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
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)
|
15/10/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
15/10/2024 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
it is a single arm open labelled study in which patients visiting OPD with the complaints of Busoor willing to undergo trial and fulfilling the inclusion criteria will be recruited. after screening the drug will be given orally for30 days.the efficacy and safety will be checked accordindly |