| CTRI Number |
CTRI/2023/03/050164 [Registered on: 01/03/2023] Trial Registered Prospectively |
| Last Modified On: |
28/02/2023 |
| 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 Randomized, Clinical Study to evaluate the Efficacy and Safety of Polyherbal Unani Formulation in Acne Vulgaris. |
|
Scientific Title of Study
|
A Randomized, Parallel Group, Open Label, Active Controlled Clinical Study to evaluate the Efficacy and Safety of a Polyherbal Unani Formulation in the Management of Buthūr Labaniyya (Acne Vulgaris) |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Tahoora Tamkanat |
| 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, Opposite ESI Hospital, Erragadda
Hyderabad
TELANGANA
500038
India |
| Phone |
8660453834 |
| Fax |
|
| Email |
tamkanattahoora@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof Arzeena Jabeen |
| 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, AG Colony road, Opposite ESI Hospital, Erragadda
Hyderabad
TELANGANA
500038
India |
| Phone |
9032519286 |
| Fax |
|
| Email |
aarzu763@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Tahoora Tamkanat |
| 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, Opposite ESI Hospital, Erragadda
Hyderabad
TELANGANA
500038
India |
| Phone |
8660453834 |
| Fax |
|
| Email |
tamkanattahoora@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, 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 |
| Tahoora Tamkanat |
National Research Institute of Unani Medicine for Skin Disorders |
OPD of Dept. of Moalajat, New OPD Block, National Research Institute of Unani Medicine for Skin Disorders, AG Colony road, Opp. ESI Hospital, Erragadda, Hyderabad 500038
Hyderabad
TELANGANA |
8660453834
tamkanattahoora@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 5% gel |
Dosage Form: Gel
Dose: As per required
Duration: 6 weeks
Mode of application: local application once daily at bed time |
| Intervention |
Polyherbal Unani Formulation |
Dosage Form: ointment
Dose: As per required
Mode of application: Local application once daily at bed time
Duration: 6 weeks
Composition:
Khub kalan (Sisymbrio irio)
Sandal surkh (Pterocarpus santalinus L.f.)
Sandal safaid (Santalum album Linn.)
Arq-e-gulab (Rosa damascena Mill.)
Powder of khub kalan, sandal surkh, sandal safaid are taken in equal quantity and is mixed with arq-e-gulab as per required |
|
|
Inclusion Criteria
|
| Age From |
15.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Both |
| Details |
1. Clinically stable patients
2. Patient having chronicity 4 months to 1 year
3. Patients having the following symptoms of Buthur Labaniyya:
Comedones
Papules
Pustules
Nodules
Itching
Erythema
|
|
| ExclusionCriteria |
| Details |
1. Patients aged <15 years or >35 years
2. Pregnant or Lactating Women
3. Patients on corticosteroid or anticonvulsant therapy or taking oral contraceptives
4. Patients suffering from other concomitant diseases, like acne rosacea, acne fulminans, acne necrotica, psoriasis, eczema, etc.
5. Significant Pulmonary/Cardiovascular/Hepato-renal Dysfunction
6. 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 |
Outcome measure will be assessed using following parameters:
1. Reduction in Global Acne Grading System
2. Reduction in Cooks Acne Grading Scale
3. Reduction in Dermatology Life Quality Index
4. Improvement in Visual Analogue Scale. |
42 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Systemic Safety Assessment |
42 days |
|
|
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)
|
05/03/2023 |
| 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
|
None yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
ButhÅ«r Labaniyya (Acne Vulgaris) is a disease of pilosebaceous unit, where lesions develop in the upper-portion of follicular canal, manifests as comedons, papules, pustules and heals with scar. It usually affects 80-90% of individuals at the time of puberty. Both the sex is equally affected. The term ButhÅ«r Labaniyya refers to a whitish discharge resembling milk from eruption. The drugs used in conventional medicine are effective, but shows after-effects after prolonged use. Hence, the safe and effective treatment for acne is required. In Unani Medicine, the drugs have JÄli, Muḥallil, Muá¹£affÄ«-i-Dam properties, but data regarding their efficacy and safety is unavailable. Hence, this clinical trial has been planned to evaluate the efficacy and safety of a polyherbal unani formulation in comparison to benzoyl peroxide 5% gel in the management of acne vulgaris. The participants fulfilling inclusion criteria will be randomly allocated to either of the groups. In test group, the patient will be given unani formulation for local application once daily at bedtime and in control group, the patients will be given benzoyl peroxide 5% gel to be applied locally once daily at bedtime. Baseline and last follow-up laboratory investigations will be done. Duration of study is 6 weeks 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. |