| CTRI Number |
CTRI/2024/02/062474 [Registered on: 09/02/2024] Trial Registered Prospectively |
| Last Modified On: |
10/01/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Unani |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
To study the effect of Unani formulation of paste in acne vulgaris. |
|
Scientific Title of Study
|
Clinical Study of Buthur Labaniyya (Acne vulgaris) and Therapeutic Evaluation of Unani Formulation of Dimad (Paste) in it’s management; An Open-label, block randomized, standard control study. |
| 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. Shameem Ahmad Rather |
| Designation |
Professor, Department of Moalijat |
| Affiliation |
Regional Research Institute of Unani Medicine (RRIUM), Srinagar |
| Address |
Department of Moalijat, RRIUM Naseem Bagh Campus, University of Kashmir, Srinagar, Jammu and Kashmir.
Srinagar JAMMU & KASHMIR 190006 India |
| Phone |
7889584083 |
| Fax |
|
| Email |
shameem.rather.SR@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Shameem Ahmad Rather |
| Designation |
Professor, Department of Moalijat |
| Affiliation |
Regional Research Institute of Unani Medicine (RRIUM), Srinagar |
| Address |
Department of Moalijat, RRIUM Naseem Bagh Campus, University of Kashmir, Srinagar, Jammu and Kashmir.
Srinagar JAMMU & KASHMIR 190006 India |
| Phone |
7889584083 |
| Fax |
|
| Email |
shameem.rather.SR@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Rifat Ara |
| Designation |
PG Scholar Moalijat |
| Affiliation |
Regional Research Institute of Unani Medicine (RRIUM), Srinagar |
| Address |
Department of Moalijat, RRIUM Naseem Bagh Campus, University of Kashmir, Srinagar, Jammu and Kashmir.
Srinagar JAMMU & KASHMIR 190006 India |
| Phone |
7006284184 |
| Fax |
|
| Email |
dr.waseem349@gmail.com |
|
|
Source of Monetary or Material Support
|
| Central Council for Research in Unani Medicine New Delhi |
|
|
Primary Sponsor
|
| Name |
Central Council for Research in Unani Medicine New Delhi |
| Address |
Regional Research Institute of Unani Medicine (RRIUM) Srinagar, CCRUM New Delhi. |
| Type of Sponsor |
Research institution |
|
|
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 |
| Shameem Ahmad Rather |
Regional Research Institute of Unani Medicine |
Moalijat OPD-1, Ground floor, Department of Moalijat, RRIUM, Naseem Bagh Campus University of Kashmir Hazratbal Srinagar Srinagar JAMMU & KASHMIR |
7889584083
shameem.rather.SR@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee for Biomedical Research (RRIUM) |
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 |
Azelaic acid cream 20% |
The Azelaic acid 20% cream will be applied on the affected areas of face at evening time for 42 days. |
| Intervention |
Dimad (Paste) |
it is a classical Unani formulation taken from Tibbi Akbar. The formulation comprises of Alsi (Linum usitatissimum), Gul-e-Surkh (Rosa damascene Mill), Kalonji (Nigella sativa) and Sirka (Vinegar).The formulation shall be applied on the affected areas of face as required at evening time for 30 minutes and then wash with water, for 42 days. |
|
|
Inclusion Criteria
|
| Age From |
15.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients of age group 15-60 years.
2. Clinically diagnosed patients of Buthur Labaniyya.
3. Patients Irrespective of the gender.
4. Patients with mild to moderate form of acne.
5. Patients who will agree to sign the informed consent form & follow the protocol. |
|
| ExclusionCriteria |
| Details |
1. Patients with severe form of acne.
2. Diagnosed patients of PCOD.
3. Patients having local wound and infection on face.
4. Pregnant and lactating women.
5. Patients with systemic diseases like DM, CKD, Chronic liver diseases,and history of Thyroid diseases or malignancies.
6. Patients on corticosteroid therapy, anti-convulsant therapy or taking OCP.
7. Patients suffering from other concomitant diseases like acne rosacea, acne fulminans, acne necrotica, psoriasis, eczema etc. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.Change in inflammatory lesions (Papules and Pustules) and non-inflammatory lesions (Open and Closed Comedones) (GAGS-Global Acne Grading System).
2) Change in the inflammatory (Papules and Pustules) lesions based on photographs of lesions.
3) Change in the quality of life of subjects based on the Dermatology Life Quality Index (DLQI). |
0th day, 7th day, 14th day, 21st day, 28th day, 35th day, 42nd day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1) Effect on redness based on Clinical Erythema Assessment (CEA).
2) Effect on eruptions based on Simple Grading System by Indian Authors. |
0th day, 7th day, 14th day, 21st day, 28th day, 35th day, 42nd day. |
|
|
Target Sample Size
|
Total Sample Size="90" Sample Size from India="90"
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 |
|
Date of First Enrollment (India)
|
15/02/2024 |
| 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 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 a self-limiting disorder of teenagers and young adults; although 10-20% of adults may continue to experience some form of the disorder. The Global burden disease (GBD) project estimates the prevalence of acne vulgaris at 9.4%, ranking it as the eighth most prevalent disease worldwide. Acne vulgaris affects both sexes equally but its age of onset is usually earlier in females (16-17 years) than in males (17-19) years. Acne vulgaris is a dermatosis of unknown etiology but androgenic stimulation at puberty is believed to increase the activity of sebaceous glands and sebum production. Sebum flow is impeded because of abnormal keratinization within the pilosebaceous canal, a process that leads to formation of comedones. Bacterial (propiobacterioum acnes) proliferation within the comedones predisposes to rupture of pilosebaceous unit with extravasations into the surrounding dermis, which results in papules, pustules, and cysts. Acne mostly occurs on face and back of neck but can also occur on chest and upper back. In Unani system of medicine, Buthur Labaniyya (Acne vulgaris) is defined as appearance of white papules on face and nose accompanied by discharge of viscous fluids from them. Unani Physicians have explained the cause of Buthur Labaniyya (acne vulgaris) as Madda-i-Sadidiya (suppurative material) which comes to the skin surface due to vapors of the body (bukharat-i-badan) and have also recommended the use of drugs (either orally or locally) having Muhalil (anti- inflammatory), Mujaffif (Desiccative) and Jali (Detergent), Dafi-Taffun (Antiseptic) properties. The allopathic approach for the treatment of Acne vulgaris is either pharmacological (Ilaj bil Dawa) or surgical (Ilaj bil Yad). Pharmacological therapies include; topical application of sulfacetamide, salicylic acid, azelaic acid and retinoid and oral administration of antibiotics (tetracycline, macrolides, clindamycin and dapsone) and anti-androgens (spironolactone, cyproterone), while as surgical procedures includes incision and curettage. Although not life threatening, acne leads to significant morbidity,including depression,anxiety,and psychosocial stress,and is the major cause of psychosocial and psychological impairment for young people triggering anxiety and mood disorders and effecting self esteem. Most of the allopathic drugs are costly, having potential adverse effects and producing only time being relief to the patients. Therefore a clinical trail entitled “Clinical Study of Buthur Labaniyya (acne vulgaris) and Therapeutic Evaluation of Unani Formulation of Dimad (Paste) in it’s management; An Open- label, block randomised, standard control studyâ€is contemplated with the objective to evaluate the therapeutic efficacy of Dimad (Paste) in acne and improve the quality of life. In this regard a Unani formulation as mentioned in classical Unani literature and comprising of Alsi (Linum usitatissimum), Gul-e-Surkh (Rosa damascene Mill), Kalonji’ (Nigella sativa) and Sirka (Vinegar) will be evaluated in the management of acne vulgaris. The above mentioned ingredients Alsi (Linum usitatissimum),Gul-e-Surkh (Rosa damascene Mill), Kalonji’ (Nigella sativa) and Sirka (Vinegar) have Muhalil (anti-inflammatory), Dafi-Taffun (Antiseptic), Mukhrij-i-Balgham (Expectorant), Mujaffif (Dessicative), Mufattih (Deobstruent) properties. |