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CTRI Number  CTRI/2024/06/069418 [Registered on: 24/06/2024] Trial Registered Prospectively
Last Modified On: 10/06/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Unani 
Study Design  Non-randomized, Active Controlled Trial 
Public Title of Study   A study to see the effect of wet cupping on Acne vulgaris. 
Scientific Title of Study   An Observational study to Evaluate the Efficacy of Hijamah Bis Shurt (Wet Cupping) in the management of Bathur Labniya (Acne vulgaris) 
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 Shiekh Zahoor Ahmad 
Designation  Medical Officer 
Affiliation  Islamic University of Science and Technology 
Address  Islamic University of Science and technology, Department: Centre for AYUSH Sciences, Ayush healyh and wellness centre, OPD no:1

Pulwama
JAMMU & KASHMIR
192122
India 
Phone  9419048318  
Fax    
Email  coordinator.ayush@iust.ac.in  
 
Details of Contact Person
Scientific Query
 
Name  Dr Shiekh Zahoor Ahmad 
Designation  Medical Officer 
Affiliation  Islamic University of Science and Technology 
Address  Islamic University of Science and Technology.Department: Centre for AYUSH Sciences, Ayush healyh and wellness centre, OPD no:1


JAMMU & KASHMIR
192122
India 
Phone  9419048318  
Fax    
Email  coordinator.ayush@iust.ac.in  
 
Details of Contact Person
Public Query
 
Name  Dr Shiekh Zahoor Ahmad 
Designation  Medical Officer 
Affiliation  Islamic University of Science and Technology 
Address  Islamic University of Science and Technology.Department: Centre for AYUSH Sciences, Ayush healyh and wellness centre, OPD no:1


JAMMU & KASHMIR
192122
India 
Phone  9419048318  
Fax    
Email  coordinator.ayush@iust.ac.in  
 
Source of Monetary or Material Support  
Islamic University of Science and technology, Awantipora,Pulwama, Jammu & Kashmir. 192122 
 
Primary Sponsor  
Name  Islamic University of Science and technology 
Address  Islamic University of Science and technology, Awantipora ,Pulwama-192122, Jammu and Kashmir, India. 
Type of Sponsor  Other [University] 
 
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 Arsheed Ganaie  AYUSH Wellness centre.  Islamic University of Science and technology.Department: Centre for AYUSH Sciences, Ayush healyh and wellness centre, OPD no:1
Pulwama
JAMMU & KASHMIR 
8491070304

arsheed.ganaie@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, Islamic University of Science and technology  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  Arq Murraqab Mussafi Khoon  Drug to be taken orally, 50ml will be given in the morning and 50ml in the evening with water daily for 2 months 
Intervention  Hijamah bis Shurt  2 medium sized cups are to applied on the back in between the two shoulder blades, after 15 days interval for 2 months 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  40.00 Year(s)
Gender  Both 
Details  1.Patients of either sex will be selected for the study.
2.Between 18 to 40 years of age.
3.Clinically Diagnosed patients with Acne vulgaris
4.Patients willing to be enrolled for the study
 
 
ExclusionCriteria 
Details  1.Patients below 18 and above 40years of age.
2.Pregnant and Lactating mothers.
3.Patients who fail to give consent.
4.Patients with systemic or metabolic diseases like DM,CVD,ObesityLiver & kidney diseases,TBetc
5.Patients suffering from Anemia and other blood dyscrasias like leukemia, hemophilia etc
6.Patients suffering with congenital diseases.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment    
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
1. Photos of lesions
2. Global Acne Severity scale (GASS) Scale
 
2 years
 
 
Secondary Outcome  
Outcome  TimePoints 
1.Comedones
2.papules
3.pustules
4.Scars
5.Erythema
6.itching
 
8 weeks 
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
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)   15/07/2024 
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="2"
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 - YES
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identification.

  2. What additional supporting information will be shared?
    Response -  Study Protocol

  3. Who will be able to view these files?
    Response - Anyone

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [tabasumfatim281@gmail.com].

  6. For how long will this data be available start date provided 05-02-2025 and end date provided 05-02-2050?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - nil
Brief Summary  

Acne vulgaris is a chronic inflammatory disease of pilosabaceous glands presenting with seborrhea,open and closed comedones,papule,pustule and nudocystic lesion in severe cases.Acne primarily affects the face,neck,uppertrunk,upperarms.It has been estemitatec that 70% of the general population have some clinically evident acne at some stage during adolescence.Acne vulgaris is among the tewn most common dermatoses found in Kashmir.As per Unani concept,BathurLabniyaare tiny ,white eruptions on nose & cheeks which resemble with condensed milk droplets.These are caused by suppurative matter which comes to surface of skin due to bukharat(vapour) of the body.30-50% of adolescents experience psychological difficulties associated with acne including body image concerns,embarrasement ,social stigma,anxiety and poor self-esteem.In modern medicine, effective treatment is available for acne vulgaris,but due to some concerns like antibiotic resistance and teratogenicity,alternative options are to be explored.Now a days Unani system of Medicine is getting authentication for the treatment of such type of disease by its unique concept which is equilibrium of humors, for this purpose different methods of treatment are applied like Ilajbil Giza (Dietotherapy), IlajbilDawa (Pharmacotherapy) , IlajbilTadbeer (Rehimenal Therapy), and IlajbilYad (Surgery). Importantly it can bring down the oral medicine burden to the patient which has to be taken for long duration. So the present study is designed“To evaluate  Efficacy of HijamahbisShurtin the management of BathurLabniya(Acne vulgaris)”.In the management of the disease more emphasis was given on the evacuation of KhiltGaleezthrough Hijamah.Hijamahis a non-pharmacological method comes under Ilaj bit Tadbeer, by this method evacuation of RaddiMawad (morbid humors) by specific method creating vacuum in between the shoulder blades.

Enrolled cases of Acne will be randomly allocated into two groups of 20 each, after obtaining a written informed consent. Group A will be allocated forHijamahbisShurt(Wet cupping) as test groupand Group B will be treated with ArqMurakkabMusaffikhoonas control group.

The pre and post treatment subjective and objective findings (effects) will be compared in both groups, and its significance will be evaluated through a suitable statistical test.

 
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