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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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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 study”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.
 
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