| CTRI Number |
CTRI/2024/04/065488 [Registered on: 09/04/2024] Trial Registered Prospectively |
| Last Modified On: |
18/02/2025 |
| 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
|
Clinical study on a topical Unani formulation in 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 (2.5%) in the Management of Buthūr
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 NAILA NAAZ |
| Designation |
PG Scholar |
| Affiliation |
National Research Institute of Unani Medicine For Skin Disorders |
| Address |
Department of Moalajat, National Research Institute of Unani Medicine For Skin Disorders,
AG Colony Road, Opp. ESI Hospital, Erragadda-500038
Hyderabad
TELANGANA
500038
India |
| Phone |
8605800473 |
| Fax |
|
| Email |
naaznaila2003@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR ASHFAQUE AHMAD |
| Designation |
Reader |
| Affiliation |
National Research Institute of Unani Medicine For Skin Disorders |
| Address |
Department of Moalajat, National Research Institute of Unani Medicine For Skin Disorders,
AG Colony Road, Opp. ESI Hospital, Erragadda-500038
Hyderabad
TELANGANA
500038
India |
| Phone |
9035268167 |
| Fax |
|
| Email |
drashfaque6@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR NAILA NAAZ |
| Designation |
PG Scholar |
| Affiliation |
National Research Institute of Unani Medicine For Skin Disorders |
| Address |
Department of Moalajat, National Research Institute of Unani Medicine For Skin Disorders,
AG Colony Road, Opp. ESI Hospital, Erragadda-500038
Hyderabad
TELANGANA
500038
India |
| Phone |
8605800473 |
| Fax |
|
| Email |
naaznaila2003@gmail.com |
|
|
Source of Monetary or Material Support
|
| NATIONAL RESEARCH INSTITUTE OF UNANI MEDICINE FOR SKIN DISORDERS |
|
|
Primary Sponsor
|
| Name |
National Research Institute of Unani Medicine For Skin Disorders |
| Address |
AG Colony Road, Opp. ESI Hospital, Erragadda-500038
Hyderabad |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| DR NAILA NAAZ |
NATIONAL RESEARCH INSTITUTE OF UNANI MEDICINE FOR SKIN DISORDERS |
OPD & IPD Of Department of Moalajat, National Research Institute of Unani Medicine For Skin Disorders, AG Colony Road, Opp. ESI Hospital, Erragadda-500038
Hyderabad
TELANGANA |
8605800473
naaznaila2003@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Communication of Decision of Institutional Ethics Committee (IEC) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: L700||Acne vulgaris, (2) ICD-10 Condition: L989||Disorder of the skin and subcutaneous tissue, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Benzoyl peroxide (2.5%) |
Sufficient quantity will be applied on affected sites twice daily |
| Intervention |
Topical Unani Formulation |
Alsi (Linum usitatissimum) will be powdered and mixed with Sirka (Vinegar) to make a paste for topical application in sufficient quantity on the affected site twice daily.
|
|
|
Inclusion Criteria
|
| Age From |
15.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Both |
| Details |
The following patients will be included in the study:
1. Participants of either gender in the age group between 15 to 35 years
2. Participants having any of the following symptoms of Buthūr Labaniyya like Comedones, Papules, Pustules ,Nodules, Itching, Erythema 3. Participants willing to give consent or assent and attend follow-up visits regularly
4.Clinically stable patients |
|
| ExclusionCriteria |
| Details |
The following patients will be excluded:
1. Patients aged less than 15 years or more than 35 years
2. Participants with other variants of acne like acne fulminans, acne rosacea, acne necrotica.
3. Patients on corticosteroid or anticonvulsant therapy or taking oral contraceptives
4. Pregnant or Lactating Women
5. Significant Pulmonary/ Cardiovascular/ Hepato-renal Dysfunction and other Disorders requiring long-term treatment
6. Known cases of Immunocompromised states (HIV/ AIDS, etc.)/ Malignancies ï‚· Patient not willing to attend treatment schedule 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 |
| Reduction in Global Acne Grading System (GAGS) |
0,2 and 4 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Patient’s Global Assessment (PGA) on VAS
2. Dermatology Life Quality Index (DLQI) Scores |
0 and 4 weeks |
|
|
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)
|
01/10/2024 |
| 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
|
Acne is a chronic inflammatory disease of the pilosebaceous units, characterized by seborrhoea, formation of open and closed comedones, erythematous papules, pustules, nodules, deeppustules and pseudocysts. Acne, the eighth most prevalent disease globally, affects 9.4% of population. Conventional treatments can cause skin irritation, burning, drying, itching and redness. In Unani medicine, many single and compound drugs are available for Buthūr Labaniyya, but many of them have not been evaluated clinically on scientific parameters. Keeping this in view, the present study is designed to evaluate the safety and efficacy of A Topical Unani formulation in the management of Buthūr Labaniyya |