| CTRI Number |
CTRI/2024/08/071810 [Registered on: 02/08/2024] Trial Registered Prospectively |
| Last Modified On: |
01/08/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Unani |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A Clinical Study to Evaluate the Efficacy of Paste in the Management of Acne Vulgaris |
|
Scientific Title of Study
|
A Clinical Study To Evaluate The Efficacy Of Zimad (Arad karasna with Shahad) In The Management Of Basoor-e-Labaniya (Acne Vulgaris) |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Ariba Javed |
| Designation |
PG scholar |
| Affiliation |
State Unani Medical College and hospital himmatganj Prayagraj, UP |
| Address |
Department of Ilaj-Bit-Tadbeer (IBT), State Unani Medical College and hospital Himmatganj
Allahabad
UTTAR PRADESH
211016
India |
| Phone |
9198782633 |
| Fax |
|
| Email |
javedariba3@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Nusrat parveen |
| Designation |
Professor |
| Affiliation |
state unani medical college, prayagraj |
| Address |
Department of Ilaj-Bit-Tadbeer (IBT), State Unani Medical College and hospital Himmatganj
Allahabad
UTTAR PRADESH
211016
India |
| Phone |
7906813040 |
| Fax |
|
| Email |
nusratparveen12755@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Ariba Javed |
| Designation |
PG scholar |
| Affiliation |
state unani medical college, prayagraj |
| Address |
Department of Ilaj-Bit-Tadbeer (IBT), State Unani Medical College and hospital Himmatganj
Allahabad
UTTAR PRADESH
211016
India |
| Phone |
9198782633 |
| Fax |
|
| Email |
javedariba3@gmail.com |
|
|
Source of Monetary or Material Support
|
| state unani medical college prayagraj , Uttar Pradesh 211016,India |
|
|
Primary Sponsor
|
| Name |
State unani medical college prayagraj, uttar pradesh |
| Address |
Department of Ilaj-Bit-Tadbeer (IBT), State Unani Medical College and hospital himmatganj Prayagraj,UP,India
PIN NO. 211016 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Ariba Javed |
State Unani Medical College and Hospital |
Department of Ilaj-Bit-Tadbeer (IBT),Room no 2 ,Ground Floor
Allahabad
UTTAR PRADESH |
9198782633
javedariba3@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee ,State Unani Medical College, Prayagraj |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: L700||Acne vulgaris, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
| Intervention |
Zimad (Aradkarasna with shahad) |
Enrolled cases of basoor-e-labaniya (acne vulgaris), after obtaining a written informed consent will be allocated with 44 patients.
Site: Face, upper back, chest.
Duration of intervention: 10-15 minutes daily.
Duration of Study: 35 days, with follow up on 0, 7th, 14th, 21th, 28th and 35th days.
|
|
|
Inclusion Criteria
|
| Age From |
15.00 Year(s) |
| Age To |
30.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients of both genders.
2. Patients who are between 15 years to 30 years.
3. Patients willing to follow protocol. |
|
| ExclusionCriteria |
| Details |
1. Patients who are under 15 years and above 30 years.
2. Known case of Diabetes Mellitus.
3. Patients on corticosteroid therapy, anti-convulsant therapy.
4. Known case of any systemic disease or concomitant disorders like acne rosacea, acne fulminans, acne necrotica, psoriasis, eczema etc.
5. Patient who do not agree to follow the study protocol.
6. Allergic patient. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.Severity of acne
2.Cook’s grading scale.
|
0,7,14,21,28,35 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Cook’s grading scale.
2. Dermatology life quality index (DLQI).
3. Improve quality of life. |
0,35 Days. |
|
|
Target Sample Size
|
Total Sample Size="44"
Sample Size from India="44"
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)
|
12/08/2024 |
| 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 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
|
Acne vulgaris is one of the oldest and commonest dermatological problem. It is one of the commonest chronic inflammatory diseases of the pilosebaceous unit with multiple pathophysiology which is excessive sebum production, Hyper keratanization, Microbial Colonization especially with Propionibacterium acnes and inflammation. Acne vulgaris clinically manifests as comedones [open(black heads) and closed(white heads)], papules, pustules, nodules, cysts and heals with scars. Acne most commonly develops on face (99%), back (60%) and chest (15%). It is most severe in late teenage years. Acne vulgaris is a pleomorphic disorder it can occurs at any time in life, most commonly it present between 12-24 years of age group and affects approximately 85% of adolescence. In modern system of medicine many topical drugs like, Adapalene, Retinoic acid, Clindamycin, Benzoyl peroxide etc are used in the treatment of acne vulgaris and many systemic drugs are also given to treat this ailment. Such as; Doxycycline, Erythromycin, Tetracycline and Oxytetracycline, but these drugs have reported many adverse effects like itching, stinging, burning, erythema, dryness, scaling, and redness even contraceptive failure. In unani medicine, acne vulgaris is treated with hijama-bil-shart (wet cupping), Irsal-e alaq (leech therapy), zimad (paste), tila (liniment), Marham (ointment)etc. to evaluate the effectiveness of these treatment, A clinical study on the effect of Zimad in managing acne vulgaris is proposed. |