| CTRI Number |
CTRI/2020/03/024029 [Registered on: 18/03/2020] Trial Registered Prospectively |
| Last Modified On: |
17/03/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug Unani |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Unani Treatment of Acne vulgaris |
|
Scientific Title of Study
|
Efficacy of Unani formulation in Busoore Labaniya (Acne vulgaris): An open labelled single arm clinical study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sultana Anjum |
| Designation |
P.G.Scholar |
| Affiliation |
National Institute Of Unani Medicine |
| Address |
Kottigepalya, magadi main road
Bangalore KARNATAKA 560091 India |
| Phone |
8210523248 |
| Fax |
|
| Email |
sultana5480@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Muzafar Din Ahmad Bhat |
| Designation |
Lecturer |
| Affiliation |
National Institute Of Unani Medicine |
| Address |
Kottigepalya, magadi main road
Bangalore KARNATAKA 560091 India |
| Phone |
9590366192 |
| Fax |
|
| Email |
drmuzaffar79@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Sultana Anjum |
| Designation |
P.G.Scholar |
| Affiliation |
National Institute Of Unani Medicine |
| Address |
Kottigepalya, magadi main road.
Bangalore KARNATAKA 560091 India |
| Phone |
8210523248 |
| Fax |
|
| Email |
sultana5480@gmail.com |
|
|
Source of Monetary or Material Support
|
| National institute of unani medicine |
|
|
Primary Sponsor
|
| Name |
National institute of unani medicine |
| Address |
Kottigepalya, magadi main road. Bangalore |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| Sultana Anjum |
National institute of unani medicine |
Kottigepalya, magadi main road Bangalore KARNATAKA |
8210523248
sultana5480@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| InsInstitutional Ethics Committee for Biomedical Research NIUM Bangalore |
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 |
Nil |
Nil |
| Intervention |
Paste of Murdar sang, Bora Armani, Roghan gul for local application
|
Murdar sang and Bora armani in equal quantity will be grinded into powder form and sieve through 100 no. mesh. Roghan gul (Q.S) will be added to this powder to make paste and stored in a jar. |
|
|
Inclusion Criteria
|
| Age From |
14.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
1- Patients of age group 14-40years, Both genders.
2- Clinically diagnosed patients of Acne vulgaris.
3- Patients/ Guardians who agree to sign the informed consent form and follow the protocol
|
|
| ExclusionCriteria |
| Details |
1- Patients who do not co-operate.
2- Age <14 and >40 years.
3- Patients having local wound and infection on face
4- Pregnant and lactating women.
5- Patient with systemic diseases like Diabetes Mellitus, hypertension.
6- Patients on corticosteroid therapy, anticonvulsant therapy, or taking OCP
7- Patient suffering from other concomitant disease like acne rosacea, acne fulminans, acne necrotica, psoriasis, eczema etc. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Improvement in Global Acne Severity Scale
photographs
Cardiff acne Disability index
|
Weekly for 4 weeks
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Improvement in QOL
Erythema
Dryness
Peeling
Burning
Itching |
Weekly for 4 weeks |
|
|
Target Sample Size
|
Total Sample Size="30" Sample Size from India="30"
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)
|
19/03/2020 |
| 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="6" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Busoore Labaniya also known as “Acne vulgaris†is one of the most common dermatosesof teenagers and young adults. The permissive factor for the expression of the disease is the increase in sebum production by sebaceous glands after puberty. The clinical hallmark of acne vulgaris is the comedone, which may be closed (whitehead) or open (blackhead) Busoore Labaniya (Acne vulgaris) is sufficiently common and often heralds the onset of puberty. The prevalence hits its peak during the middle-to-late teenaged period with more than 85% of adolescents affected. A prevalence of acne in women between ages 26 and 44yrs is to be 14%.It is characterized by seborrhea, open and closed comedones, erythematous papules, pustules and in more severe cases nodules, deep pustules and pseudocysts.According to the Global Burden disease (GBD) study it affects 85% of young adult aged 12-25 years. Acne consistently represents the top three most prevalent skin condition in the general population, as found in large studies with in the UK, FRANCE and the USA. It leads to significant morbidity associated with residual scarring and psychological disturbances such as poor self – image, depression, and anxiety, which leads to a negative impact on quality of life. In conventional therapies, Busoore Labaniya is treated either pharmacologically or surgically. Pharmacological therapy includes topical application of retinoids or oral administration of antibiotics and anti-androgens, while surgical intervention includes incision and curettage of cysts.The long term use of these treatment modalities are often associated with certain side effects like erythema, irritation, peeling, burning, drying and bleaching of skin; use of isotretinoin has teratogenic effects and tetracycline causes gastrointestinal discomfort and diarrhea, etc. Therefore, there is a dire need to develop a safe and effective regimen for the management of Busoore Labaniya. In view of high prevalence, side effect of drugs of conventional medicine, present study has been designed to validate the effect of paste in Busoore Labaniya (Acne Vulgaris). The ingredients of formulations are Murdarsang, Bora Armani and Roghan gul. Function of Murdarsang is Jali (detergent), Akkal (corrosive), Mujaffif (desiccative), Muhallil (resolvent), Qabiz (astringent), Mukhrij balgham (expectorant). The function of Bora Armani is Jali (detergent), Mujaffif (desiccative), Muhallil (resolvent), Mukhrij belgham (expectorant), Gussal (lavage), Dafa-Taffun(antiseptic), Qabiz (astringent). The function of Roghan gul is Radah (derivative), Qabiz (astringent), Muhallil (resolvent), Mufattih (deobstruent), Musakkin (analgesics). |