| CTRI Number |
CTRI/2023/10/058541 [Registered on: 11/10/2023] Trial Registered Prospectively |
| Last Modified On: |
07/10/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Unani |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Evaluating efficacy of unani formulation in Acne. |
|
Scientific Title of Study
|
A Randomized, Parallel Group, Open Label, Active Controlled Clinical Study to Evaluate the Efficacy and Safety of a Unani Pharmacopeial Formulation Marham Hina in the Management of Buthur Labaniyya (Acne Vulgaris). |
| Trial Acronym |
NA |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Khan Shama Rahimullah |
| Designation |
P.G Scholar |
| Affiliation |
National Research Institute of Unani Medicine for Skin Disorders |
| Address |
Department of Moalajat, National Research Institute of Unani Medicine for Skin Disorders, AGs Colony Road, Opposite ESI Hospital,
Erragadda,Hyderabad 500038
Hyderabad
TELANGANA
500038
India |
| Phone |
8999285065 |
| Fax |
|
| Email |
khanshama41@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof Mohammad Nawab |
| Designation |
Professor |
| Affiliation |
National Research Institute of Unani Medicine for Skin Disorders |
| Address |
Department of Moalajat, National Research Institute of Unani Medicine for
Skin Disorders. AGs Colony Road, Opp. ESI Hospital, Erragadda,
Hyderabad- 500038
Hyderabad
TELANGANA
500038
India |
| Phone |
8100992044 |
| Fax |
|
| Email |
ccrumnawab@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Khan Shama Rahimullah |
| Designation |
P.G Scholar |
| Affiliation |
National Research Institute of Unani Medicine for Skin Disorders |
| Address |
Department of Moalajat, National Research Institute of Unani Medicine for Skin Disorders, AGs Colony Road, Opposite ESI Hospital,
Erragadda,Hyderabad 500038
Hyderabad
TELANGANA
500038
India |
| Phone |
8999285065 |
| Fax |
|
| Email |
khanshama41@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 |
AGs Colony Road, Opp. 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 Khan Shama Rahimullah |
National Research Institute of Unani Medicine for Skin Disorders. |
OPD & IPD of Department of
Moalajat, National
Research Institute of
Unani Medicine for Skin
Disorders. AGs Colony
Road, Opp. ESI
Hospital, Erragadda,
Hyderabad- 500038
Hyderabad
TELANGANA |
8999285065
khanshama41@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, NRIUMSD, Hyderabad |
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 |
Benzoyl Peroxide 2.5% Gel |
1.Dose: As per requirement at affected sites
2. Frequency : Twice a day
3. Route of administration : Local Application
4. Total duration : 6 weeks
5. Dosage Form: Gel
|
| Intervention |
Marham Hina |
1.Dose: As per requirement at affected sites
2. Frequency : Twice a day
3. Route of administration : Local Application
4. Total duration : 6 weeks
5. Dosage Form: Marham (Ointment)
Composition:1.Roughan-e- Hina (Lawsonia inermis,
Linn.)2.Kafoor Khalis (Cinnamomum camphora, Nees.)
3. Sat-e- Pudina (Mentha arvensis, Linn.) 4.Sat-e-Ajwayin (Trachyspermum ammi, Linn.)
5.Mom Khalis (Cera Alba )
6.Petroleum jelly
|
|
|
Inclusion Criteria
|
| Age From |
12.00 Year(s) |
| Age To |
30.00 Year(s) |
| Gender |
Both |
| Details |
Participants of any gender in the age group between 12 to 30 years.
Participants having any of the following symptoms of Buthur Labaniyya as Comedones, Papules,Pustules ,Nodules, Itching , Erythema.
Participants who are willing to participate and comply with the protocol and to sign IEC approved informed consent / assent form.
|
|
| ExclusionCriteria |
| Details |
Participants aged <12 years and > 30 years.
Participants with other variants of acne like acne fulminans, acne rosacea, acne necrotica.
Participants suffering from other concomitant diseases like vitiligo, dermatophytosis, psoriasis and eczema.
Pregnant or Nursing Women.
|
|
|
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 |
25% Reduction in Global Acne Grading System Score from baseline
|
6 Weeks
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Reduction in Cooks Acne Grading Scale , Dermatology Life Quality Index , Visual Analogue Scale Score from baseline
2. Improvement in symptoms from baseline
|
6 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)
|
16/10/2023 |
| 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 Applicable |
| 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 the most common skin disease, affect 9.4% of the global population, making it the eighth most prevalent disease worldwide. According to the GBD study, acne vulgaris affects ~85% of young adults’ aged 12–25 years. Acne causes disfigurement which leads to great psychological, emotional and social impact. Anxiety, depression, bullying, lack of confidence, social withdrawal, feelings of insecurity and inferiority even suicidal ideation. In conventional therapy, there are many drugs are available but none of them are free from side effects. Marham hina, is a potent topical treatment from National Formulary of Unani Medicine for Acne Vulgaris.
This Randomized, Active controlled, Parallel Group, Open Label, Clinical study has planned to evaluate the Efficacy and Safety of Marham Hina 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 Marham Hina ointment local application twice daily at affected sites as per requirement, in control drug participants will be given benzoyl peroxide 2.5% gel topically twice daily at affected sites as per requirement. Laboratory investigation will be done at baseline and last follow up. Duration of the study is 6 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.
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