| CTRI Number |
CTRI/2024/02/063169 [Registered on: 26/02/2024] Trial Registered Prospectively |
| Last Modified On: |
29/01/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Unani |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Evaluation of efficacy and safety of a topical polyherbal Unani formulation in Acne Vulgaris.
|
|
Scientific Title of Study
|
Evaluation of efficacy and safety of a topical Unani formulation in
ButhuÖ¿r Labaniyya (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 |
Dr Atoofa |
| Designation |
MD Scholar |
| Affiliation |
Hakim Syed Ziaul Hasan Government Unani Medical College and Hospital |
| Address |
Department of Amraze Jild Wa Tazeeniyat,OPD No.5 Hakim Syed Ziaul Hasan Government Unani Medical College and Hospital Ayush Campus Kolar Bypass Road Bhopal Madhya Pradesh
Bhopal
MADHYA PRADESH
462003
India |
| Phone |
8826016465 |
| Fax |
|
| Email |
atufakhalid2212@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Dilshad Ali |
| Designation |
Associate Professor |
| Affiliation |
Hakim Syed Ziaul Hasan Government Unani Medical College and Hospital |
| Address |
Department of Amraze Jild Wa Tazeeniyat,OPD No.5 Hakim Syed Ziaul Hasan Government Unani Medical College and Hospital Ayush Campus Kolar Bypass Road Bhopal Madhya Pradesh
Bhopal
MADHYA PRADESH
462003
India |
| Phone |
9827140209 |
| Fax |
|
| Email |
dilshadali28@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Atoofa |
| Designation |
MD Scholar |
| Affiliation |
Hakim Syed Ziaul Hasan Government Unani Medical College and Hospital |
| Address |
Department of Amraze Jild Wa Tazeeniyat,OPD No.5 Hakim Syed Ziaul Hasan Government Unani Medical College and Hospital Ayush Campus Kolar Bypass Road Bhopal Madhya Pradesh
Bhopal
MADHYA PRADESH
462003
India |
| Phone |
8826016465 |
| Fax |
|
| Email |
atufakhalid2212@gmail.com |
|
|
Source of Monetary or Material Support
|
| Hakim Syed Ziaul Hasan Government Unani Medical College and Hospital and Madhya Pradesh Medical Science University Jabalpur |
|
|
Primary Sponsor
|
| Name |
Hakim Syed Ziaul Hasan Government Unani Medical College and Hospital |
| Address |
Hakim Syed Ziaul Hasan Government Unani Medical College and Hospital Ayush Campus Kolar Bypass Road Bhopal Madhya Pradesh 462003 |
| 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 Atoofa |
Hakim Syed Ziaul Hasan Government Unani Medical College and Hospital |
OPD No.5 Department of Amraze Jild Wa Tazeeniyat Hakim Syed Ziaul Hasan Government Unani Medical College and Hospital Ayush Campus Kolar Bypass Road Bhopal Madhya Pradesh 462003
Bhopal
MADHYA PRADESH |
8826016465
atufakhalid2212@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Instituitional Ethics Committe Hakim Syed Ziaul Hasan Government Unani Medical College and Hospital |
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 |
Clindamycin 1% gel |
Marketed formulation of Clindamycin 1% gel provided to the patient and will be instructed to wash face and after drying the affected part by the clean towel, patients will be instructed to apply Clindamycin 1% gel topically only on the affected area, once at night and will be asked to leave it overnight followed by washing in the morning for 6 weeks. |
| Intervention |
ṬilÄ’ (Thin paste) consists of fine powder of Irsa (Root of Iris ensata), Post-e-Siras
(Bark of Albizia lebbeck), and Barg-e-Neem (Leaves of Azadirachta indica) in equal proportion, mixed with Arq-e-Gulab to make tila a thin homogenous paste. |
A topical unani formulation, tila (Thin paste) which consists of fine powder of Irsa (Root of Iris ensata), Post-e-Siras(Bark of Albizia lebbeck), and Barg-e-Neem (Leaves of Azadirachta indica) in equal proportion, mixed with Arq-e-Gulab to make thin homogenous paste and then patient will be asked to wash face and after drying the affected part by the clean towel, then patients will be instructed to apply the test drug (ṬilÄ’) 5-10gram (keeping in view of the area involved) of this formulation mixed with Arq-e-Gulab on the acne-affected area once at night and will be asked to leave it overnight followed by washing in the morning for 6 weeks. |
|
|
Inclusion Criteria
|
| Age From |
13.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
1) Patients of either sex.
2) Patients of 13 to 40 years of age.
3) Mild to moderate acne as defined by the Global Acne Grading System (GAGS) scale.
4) Patients willing to sign the informed consent form. |
|
| ExclusionCriteria |
| Details |
1) Patients suffering from any skin disease like vitiligo, psoriasis, eczema, etc.
2) Immunocompromised condition.
3) Any active psychiatric illness.
4) Pregnant and lactating women.
5) Patients with any systemic illness such as the known case of DM, HTN, etc. which might interfere with the follow-up and assessment during our study.
|
|
|
Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Change in Global Acne Grading System Scale (GAGS) of Acne
vulgaris, from baseline to end of treatment. |
Baseline,2nd week,4th week,6th week |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| DLQI (Dermatology Life Quality Index) |
Baseline and 6th week |
|
|
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 |
|
Date of First Enrollment (India)
|
01/03/2024 |
| 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="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
|
ButhuÖ¿r Labaniyya (Acne vulgaris) is a chronic inflammatory disease of the pilosebaceous units and is characterized by seborrhea, the formation of comedones, erythematous papules and pustules, less frequently by nodules, and, in some cases, is accompanied by scarring. The main cause of acne is excessive sebum production, and microbial colonization by Propionibacterium acne. According to classical Unani literature, the main cause of ButhuÖ¿r Labaniyya is the hyperactivity of Ghudud-e-Dohniya (sebaceous glands), which results in increased production of oily material, which gets clogged into the openings of these glands, and then inflamed, which remains unresolved in the skin. It is estimated to affect 9.4% of the global population, making it the eighth most prevalent disease worldwide.In India, acne is prevalent in 72.3% of adolescents and 27% of the adult age group. In modern system of medicine, which includes topical and systemic antibiotics, such as benzoyl peroxide, doxycycline, clindamycin, etc. and retinoids are also infrequently used. These drugs have several limitations, long-term use of these medications causes serious adverse effects such as erythema, peeling, burning, and drying of the skin. Additionally, Propionibacterium acne drug resistance may restrict the use of topical antibiotics and producing only symptomatic relief. In the classical literature of Unani, a number of formulations and single drugs are mentioned for the management of acne and also very effective in scar prevention. These polyherbal medications mainly have Jali (Detergent), Muhalil (Resolvent), and Mujaffif (Desiccative) properties and have been used by ancient Unani physicians for centuries to treat ButhuÖ¿r Labaniyya.This polyherbal topical Unani formulation is selected from Al-Qarabadin and ḤÄziq which includes, Irsa (Iris ensata), Post-e-Siras (Albizia lebbeck) and Barg-e-Neem (Azadirachta indica) will be evaluated in the management of ButhuÖ¿r Labaniyya. |