| CTRI Number |
CTRI/2025/11/097575 [Registered on: 17/11/2025] Trial Registered Prospectively |
| Last Modified On: |
15/11/2025 |
| 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
|
A Clinical Study to compare unani formulation with benzoyl peroxide cream for Acne |
|
Scientific Title of Study
|
A Randomized, Parallel Group, Open Label, Active Controlled Clinical Study to Evaluate the Safety and Efficacy of a Topical Unani Formulation compared with Benzoyl Peroxide (5 Percent) in the Management of Buthur 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 Shaikh Nazia Rashid Ahmed |
| Designation |
PG Scholar |
| Affiliation |
National Research Institute of Unani Medicine for Skin Disorders (NRIUMSD), Hyderabad |
| Address |
National Research Institute of Unani Medicine
for Skin Disorders (NRIUMSD),
AG Colony Road, Opp. ESI Hospital,
Erragadda, Hyderabad-500 038
Hyderabad
TELANGANA
500038
India |
| Phone |
9967872770 |
| Fax |
|
| Email |
naziashaikh267@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof Qamar Uddin |
| Designation |
Professor |
| Affiliation |
National Research Institute of Unani Medicine for Skin Disorders (NRIUMSD), Hyderabad |
| Address |
National Research Institute of Unani Medicine
for Skin Disorders (NRIUMSD),
AG Colony Road, Opp. ESI Hospital,
Erragadda, Hyderabad-500 038
Hyderabad
TELANGANA
500038
India |
| Phone |
8700027178 |
| Fax |
|
| Email |
qamaruddindr@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shaikh Nazia Rashid Ahmed |
| Designation |
PG Scholar |
| Affiliation |
National Research Institute of Unani Medicine for Skin Disorders (NRIUMSD), Hyderabad |
| Address |
National Research Institute of Unani Medicine
for Skin Disorders (NRIUMSD),
AG Colony Road, Opp. ESI Hospital,
Erragadda, Hyderabad-500 038
Hyderabad
TELANGANA
500038
India |
| Phone |
9967872770 |
| Fax |
|
| Email |
naziashaikh267@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
National Research Institute of Unani Medicine for Skin Disorders (NRIUMSD), Hyderabad |
| Address |
AG Colony Road, Opp. ESI Hospital,
Erragadda, Hyderabad-500 038 |
| 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 Shaikh Nazia Rashid Ahmed |
National Research Institute of Unani Medicine for Skin Disorders (NRIUMSD) |
OPD:Room No-01 Of DEPARTMENT OF MOALAJAT,NRIUMSD, AG Colony Road, Opp.ESI Hospital,
Erragadda, Hyderabad-500 038
Hyderabad
TELANGANA |
9967872770
naziashaikh267@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committe |
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 |
Active Controlled Drug (Topical) |
Composition: Benzoyl Peroxide 5% Cream
Dosage And Route:
Participants in control group will be advised to apply Benzoyl Peroxide 5 Percent Cream in sufficeint Quantity locally on the affected site once daily.
Duration Of Therapy:42 Days |
| Intervention |
Topical Unani Formulation |
Composition:Kaf e Darya-1Part
Haldi-1Part
Method Of Prepration:The drug will be prepared as per the guidelines specified in the UnaniPharmacopoeia of India (UPI). Both the ingredients will be cleaned and then a fine powder will be made using pulverizer. The powdered drug will be passed through a sieve of mesh size 60 to obtain uniform particlesize, and then packed into airtight containers, each containing 30 gramof the standardized powder.
Dosage And Route:Participant will be advised to make a paste of TopicalUnani Formulation with Arq Gulab and apply topically on the affectedsite daily at night, and wash off with water after 2 hours.
Duration Of Therapy:42 Days |
|
|
Inclusion Criteria
|
| Age From |
14.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
The following Participants will be included in the study:
a) Participants of any sex in the age group between 14 and 40Years
b)Clinically stable patients
c) Participants having the following signs & symptoms of Buthur Labaniyya:
Comedones
Papules
Pustules
Nodules
Itching
Erythema |
|
| ExclusionCriteria |
| Details |
The following Participants will be excluded from the study:
a)Participants aged Less then 14 years or More then 40 years
b)Pregnant or Lactating Women
c) Mentally retarded person
d)Patients on corticosteroid or anticonvulsant therapy or taking oral contraceptives
e)Patients suffering from other concomitant diseases, like acne rosacea, acne fulminans, acne necrotica, psoriasis, eczema,etc.
f)Significant Pulmonary,Cardiovascular,Hepato-renal Dysfunction.
g)Patient not willing to attend treatment schedules regularly.
|
|
|
Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Primary Outcome Measures
1. Change in Global Acne Grading System (GAGS) Score from baseline to 6 weeks of treatment
2. Change in Cook’s Acne Grading Scale (CAGS) Score from
baseline to 6 weeks of treatment
3. Change in Patient’s Global Assessment (PGA) on VAS from baseline to end of 6 weeks
4. Change in Period of Clinical Recovery from baseline to week 6 |
Participants will be followed-up for evaluation at 2, 4, & 6 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Evaluation of Safety by:
a.Monitoring Adverse Events (AEs):
Adverse effects related to either the Unani drug or control drug will be documented at each clinical assessment visit (weeks 2, 4, and 6 week both as reported by the participants, and observed by the physician during clinical examination.
b.Changes in Laboratory Parameters (performed at baseline and at week 6)
-Haemogram( Hb, TLC, DLC, RBC Count, Platelet Count, ESR,FBS)
-Liver Function Test (Bilirubin, SGOT, SGPT, S. Alkaline Phosphatase)
-Kidney Function Test (Serum Creatinine, Blood Urea)
-Urine Examination (Routine & Microscopic)
2.Change in DLQI score from baseline to week 6
|
Follow up at 2 And 6week |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
01/01/2026 |
| 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
|
Buthur Labaniyya (Acne vulgaris) is a common disorder of the pilosebaceous unit affecting adolescents, often leading to scarring and psychosocial impact. Conventional drugs provide relief but have adverse effects and high recurrence. Unani medicine describes effective formulations with Jali(detergent), Muhallil (resolvent), and Mujaffif (desiccative) properties. Haldi(Curcuma longa) and Kaf-i-Darya (cuttlefish bone) are traditionally used for their anti-inflammatory, antiseptic, and blood-purifying actions. This clinical study aims to scientifically evaluate the safety and efficacy of a topical Unani formulation versus Benzoyl Peroxide in acne management, generating evidence-based support for Unani interventions in dermatological care. |