| 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
|
|
|
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
|
|
|
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
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identification.
- What additional supporting information will be shared?
Response - Study Protocol
- Who will be able to view these files?
Response - Anyone
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [tabasumfatim281@gmail.com].
- 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.
- 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)â€.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.
|