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CTRI Number  CTRI/2023/03/050493 [Registered on: 09/03/2023] Trial Registered Prospectively
Last Modified On: 03/03/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Unani 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   To study the effects of a Unani formulation in patients with Acne. 
Scientific Title of Study   Evaluating the therapeutic effects of a Unani Formulation of Lattukh (smear) in the management of Buthur Labaniyya (Acne vulgaris): A single blind, randomized, standard control study.  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Mahvish Mehraj 
Designation  PG Scholar 
Affiliation  Regional Research Institute of Unani Medicine (RRIUM), Srinagar 
Address  Department of Moalajat RRIUM Naseem Bagh Campus of University of Kashmir Srinagar Jammu and Kashmir

Srinagar
JAMMU & KASHMIR
190006
India 
Phone  7006565905  
Fax    
Email  mehvishmehraj8@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Zaffar Hussain 
Designation  Professor and HOD Department of Moalajat 
Affiliation  Regional Research Institute of Unani Medicine (RRIUM), Srinagar 
Address  Department of Moalajat RRIUM Naseem Bagh Campus of University of Kashmir Srinagar Jammu and Kashmir

Srinagar
JAMMU & KASHMIR
190006
India 
Phone  7006021996  
Fax    
Email  hussainzaffar6@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Zaffar Hussain 
Designation  Professor and HOD Department of Moalajat 
Affiliation  Regional Research Institute of Unani Medicine (RRIUM), Srinagar 
Address  Department of Moalajat RRIUM Naseem Bagh Campus of University of Kashmir Srinagar Jammu and Kashmir

Srinagar
JAMMU & KASHMIR
190006
India 
Phone  7006021996  
Fax    
Email  hussainzaffar6@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),University of Kashmir, 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 
Dr Mahvish Mehraj  Regional Research Institute of Unani Medicine  Moalajat OPD-1, Ground floor, Department of Moalajat, RRIUM, Naseembagh Campus University of Kashmir Hazratbal
Srinagar
JAMMU & KASHMIR 
7006565905

mehvishmehraj8@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, RRIUM Srinagar  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  Clindamycin  Clindamycin 1% shall be applied locally over affected areas at bedtime for 40 days. 
Intervention  Lattukh (Smear)  It is a classical Unani formulation taken from Canon of Medicine. The formulation comprises of Injir (Ficus carica Linn) (dried fruit), Kalonji (Nigella sativa) (seeds) and Sirka [Sirka angoori ( Grape vinegar)]. The formulation shall be applied locally over affected areas at bedtime for 40 days. 
 
Inclusion Criteria  
Age From  12.00 Year(s)
Age To  40.00 Year(s)
Gender  Both 
Details  1) Patients of age between 12-40 years.
2) Patients with mild to moderate forms of acne.
3) Irrespective of gender.
4) Patients with itching, erythema, comedones,
papules and pustules.
5) Patients who are willing to give consent and
are able to follow up.
 
 
ExclusionCriteria 
Details  1) Patients below 12 years and above 40 years of
age.
2) Patients with severe forms of acne.
3) Diagnosed patients of PCOS.
4) Pregnant and lactating women.
5) Patients on corticosteroid therapy and on
OCP’s.
6) Patients suffering from systemic illnesses like
Cardiovascular disease, chronic kidney disease
and chronic liver disease, thyroid disease or
malignancy.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   On-site computer system 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
1) Change from baseline to day 41st in the inflammatory (Papules and pustules) lesions and non-inflammatory (open and closed comedones) lesions (GAGS- Global Acne Grading System).
2) Change from baseline to day 41st in Investigator’s Global Assessment of Acne (IGA).
3) Change from baseline to day 41st day in the inflammatory (papules and pustules) lesions
based on photographs of lesions.
4) Change from baseline to day 41st day in the quality of life of subjects based on the Dermatology Life Quality Index (DLQI).

 
40 days. 
 
Secondary Outcome  
Outcome  TimePoints 

1)Effect on itching based on Visual Analogue Scale (VAS).
2) Effect on redness based on Clinical Erythema Assessment (CEA).
3) Effect on eruptions based on Simple Grading System by Indian Authors.  
40 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 
Date of First Enrollment (India)   10/03/2023 
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    
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

Acne vulgaris is a common skin condition characterized by comedones, inflammatory lesions like papules, pustules, nodules and cysts; and scars mainly on face, chest and upper back. The prevalence of Acne vulgaris is believed to be 85% among teenagers and young adults, making it one of the most prevalent skin diseases worldwide. The lesions disappear in the third decade of life in roughly 70% of patients. Both the genders are equally affected; however, men are roughly ten times more likely to develop nodulocystic acne. A lot of mental issues are frequently linked to have a relatively disfiguring skin condition during a time when a person is developing his social identity. Acne vulgaris is a major contributor to psychosocial and psychological impairment in young people, causing anxiety and mood disorders and lowering self-esteem, even though it is not life threatening. The incidence of Acne vulgaris appears to be increasing globally. Acne vulgaris has been recognized and described by various Unani physicians. It has been described as small, white lesions on the nose and cheeks, resembling droplets of condensed milk and as the lesions mature and develop fully, they exude peep (pus). The Madda-i-á¹¢adidiya (infected matter) that causes these lesions is brought to the skin surface by the bukarat-i-badan (body vapours) and the condition is treated with drugs having Tajfif (desiccant) and Tahlil (resolving) properties. The formulation of Lattukh (smear) consists of Injir (Ficus carica Linn), Kalonji (Nigella sativa) and Sirka ( Grape vinegar) and all the three drugs possess the above mentioned properties. In contemporary system of medicine, there are many treatment modalities available but all have side effects, and pose an economical burden and some people don’t respond well to them. The management of Acne vulgaris depends on its severity and subtype. Topical medications like benzoyl peroxide, retinoids, and topical antibiotics can be used to combat mild to moderate forms of Acne vulgaris, however, each of them develops side effects like xerosis, erythema, skin irritation such as itching, burning and stinging sensation. Oral antibiotics like tetracyclines, macrolides and clindamycin can be used with topical medications to alleviate moderate to severe forms of Acne vulgaris but have associated detrimental effects such as nausea, vomiting or diarrhoea, abdominal pain; hypersensitivity reactions (pneumonitis, eosinophilic nephritis, serum sickness), autoimmune disorders (SLE, autoimmune hepatitis, polyarthritis nodosa), dizziness, headache, and photosensitivity associated with tetracyclines. Acne vulgaris in females can be treated with hormonal therapy, such as spironolactone or combination oral contraceptives. Isotretinoin, a systemic retinoid, is the treatment of choice for severe nodulocystic acne. Although it is quite successful, it can have major detrimental effects, such as teratogenicity and psychiatric side effects, and it needs to be closely monitored. The necessity to authenticate the activity of Unani drugs, which are safe, effective, and have limited side effects, emerges in view of aforementioned facts in order to cure the condition and enhance the quality of life.

 
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