| CTRI Number |
CTRI/2025/03/082481 [Registered on: 17/03/2025] Trial Registered Prospectively |
| Last Modified On: |
11/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Unani |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A clinical trial to study the effects of two topical applications, Adapalene (0.1 percent) and Topical Unani Formulation in patients with Acne Vulgaris . |
|
Scientific Title of Study
|
A RANDOMIZED, PARALLEL GROUP, OPEN LABEL, ACTIVE CONTROLLED CLINICAL STUDY TO COMPARE THE SAFETY AND EFFICACY OF A TOPICAL UNANI FORMULATION WITH ADAPALENE (0.1 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 Sofia Sad |
| Designation |
PG Scholar |
| Affiliation |
National Research Institute of Unani Medicine for Skin Disorders |
| Address |
NRIUMSD, Department of Moalajat, National Research Institute of Unani Medicine for Skin Disorders, AG Colony Road, Opposite ESI Hospital, Erragadda, Hyderabad
Hyderabad
TELANGANA
500038
India |
| Phone |
9899531824 |
| Fax |
|
| Email |
sofiasad.ss@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ashfaque Alam |
| Designation |
Reader |
| Affiliation |
National Research Institute of Unani Medicine for Skin Disorders |
| Address |
NRIUMSD
Department of Moalajat, AG Colony Road, Opposite ESI Hospital, Erragadda, Hyderabad
Hyderabad
TELANGANA
500038
India |
| Phone |
8103161174 |
| Fax |
|
| Email |
drashfaque6@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ashfaque Alam |
| Designation |
Reader |
| Affiliation |
National Research Institute of Unani Medicine for Skin Disorders |
| Address |
NRIUMSD
Department of Moalajat, AG Colony Road, Opposite ESI Hospital, Erragadda, Hyderabad
Hyderabad
TELANGANA
500038
India |
| Phone |
8103161174 |
| Fax |
|
| Email |
drashfaque6@gmail.com |
|
|
Source of Monetary or Material Support
|
| National Research Institute of Unani Medicine for Skin Disorders, Erragadda, Hyderabad, 500038 |
|
|
Primary Sponsor
|
| Name |
National Research Institute of Unani Medicine for Skin Disorders |
| Address |
NRIUMSD, AG Colony Road, Opposite ESI Hospital, Erragadda, Hyderabad, 500038 |
| 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 Sofia Sad |
OPD and IPD of Department of Moalajat, NRIUMSD. |
AG Colony Road, Erragadda
Hyderabad
TELANGANA |
9899531824
sofiasad.ss@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Communication of Dissertation 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, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Adapalene (0.1%) |
Dosage Form : Gel
Dose : As per requirement Topical application once a day.
|
| Intervention |
Topical Unani Formulation |
Dimad containing Kaf-e-dariya, Mom (Wax),Roghan-e-gul will be topically applied once a day on lesion.
|
|
|
Inclusion Criteria
|
| Age From |
15.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Both |
| Details |
1.Clinically diagnosed cases of acne vulgaris. 2.Individuals exhibiting any of the subsequent signs and symptoms of Buthur Labaniyya (Comedones, Papules, Pustules, Nodules, Itching, Erythema). GAGS score less than 30. Clinically stable patients.
3.Participants who are competent to follow up and who will provide assent.
|
|
| ExclusionCriteria |
| Details |
1.Individuals who are under 15 or older than 35.
2.Patients with GAGS score more than 30.
3.Individuals who suffer from other types of acne, such as eczema, rosacea, acne necrotica, or acne fulminans.
4.Patients undergoing oral contraceptive or androgen medication, or receiving corticosteroid or anticonvulsant therapy .
5.Pregnant or Lactating Women.Significant Pulmonary/ Cardiovascular/ Hepato-Renal dysfunction and other disorders requiring long-term treatment.Known cases of immunocompromised states (HIV/ AIDS etc.) Malignancies.
6.Patient who have used isotretinoin in last six months. |
|
|
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 |
| Change in GAGS. |
0,2 and 4 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Change in PGA, DLQI Score from baseline
2.Improvement in symptoms from baseline
|
0,2 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)
|
01/06/2025 |
| 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="8"
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
|
Overall prevalence of Acne worldwide consists of 20.5%.The Prevalence was highest among the age group 16 to 24, reaching 28.4%. Drugs used in conventional medicines are effective, but these drugs are associated with multiple side effects. Keeping all these facts in consideration, Keeoing all these facts in considerations, A topical Unani Formulation given by Hakeem Mohammad Azam Khan (1814-1902), for Buthur Labaniyya is used for this clinical trial. This Randomized, Active controlled, Parallel Group, Open Label, Clinical study has planned to evaluate the Efficacy and Safety of a Topical Unani Formulation in the management of acne vulgaris. Participants fulfilling inclusion and exclusion criteria will be receive either test or control drug as per randomization, in test group participants will be receive Topical Unani Formulation as ointment for local application once daily at affected sites as per requirement, in control drug participants will be given Adapalene 0.1% gel topically once daily at affected sites as per requirement. Laboratory investigation will be done at baseline and last follow up. Duration of the study is 4 weeks. For statistical analysis Student t test will be used to find the statistically significant difference in the parameters within the group/ inter the group. All the result analysis will be done using MS excel 2019. |