| CTRI Number |
CTRI/2017/12/010957 [Registered on: 21/12/2017] Trial Registered Prospectively |
| Last Modified On: |
19/12/2017 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Unani |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Treatment of ithy, red, dry and cracked skin condition (Eczema) by of Unani drug |
|
Scientific Title of Study
|
A Clinical Study to Evaluate the Efficacy and Safety of Marham-e-Safeda Kafoori in the Management of Nar Farsi (Eczema) |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Khurshid Alam |
| Designation |
PG Scholar |
| Affiliation |
Central Research Institute of Unani Medicine, Hyderabad |
| Address |
Deptt. of Moalajat, Central Research Institute of Unani Medicine, Opp. ESI Hospital, AG Colony Road, Erragadda, Hyderabad
Hyderabad ANDHRA PRADESH 500038 India |
| Phone |
8791430329 |
| Fax |
|
| Email |
khursheed6459@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Mohammad Nawab |
| Designation |
Reader |
| Affiliation |
Central Research Institute of Unani Medicine, Hyderabad |
| Address |
Deptt. of Moalajat, Central Research Institute of Unani Medicine, Opp. ESI Hospital, AG Colony Road, Erragadda, Hyderabad
Hyderabad ANDHRA PRADESH 500038 India |
| Phone |
8100992044 |
| Fax |
|
| Email |
ccrumnawab@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Prof Qamar Uddin |
| Designation |
Professor and HoD Moalajat |
| Affiliation |
Central Research Institute of Unani Medicine, Hyderabad |
| Address |
Deptt. of Moalajat, Central Research Institute of Unani Medicine, Opp. ESI Hospital, AG Colony Road, Erragadda, Hyderabad
Hyderabad ANDHRA PRADESH 500038 India |
| Phone |
8700027178 |
| Fax |
|
| Email |
ccrumhqrsnd58@gmail.com |
|
|
Source of Monetary or Material Support
|
| Central Research Institute of Unani Medicine, Opp. ESI Hospital, AG Colony Road, Erragadda, Hyderabad, Telangana, 500038 |
|
|
Primary Sponsor
|
| Name |
Central Research Institute of Unani Medicine |
| Address |
Central Research Institute of Unani Medicine, Opp. ESI Hospital, AG Colony Road, Erragadda, Hyderabad, Telangana, 500038 |
| 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 |
| Khurshid Alam |
Central Research Institute of Unani Medicine |
Deptt. of Moalajat, OPD no. 1, Ground floor, New OPD block, Central Research Institute of Unani Medicine, Opp. ESI Hospital, AG Colony Road, Erragadda, 500038 Hyderabad ANDHRA PRADESH |
8791430329
khursheed6459@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee CRIUM Hyderabad |
Approved |
|
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Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Nar Farsi (Eczema), |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Control Group : Clobetasol propionate |
Dosage form: Ointment
Route of Adminstration: Local
|
| Intervention |
Study Drug: Marham-e-Safeda Kafoori |
Topical application on affected parts.
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients of any sex in the age group of 18 to 65 years
2. Patients having the following symptoms:
3. Erythema
4. Scaling
5. Lichenification
6. Excoriation
Hyperpigmentation
Burnig Sensation
Itching
|
|
| ExclusionCriteria |
| Details |
1. Patients aged below 18 years and above 65 years
2. Patients on concomitant therapy
3. Co-morbid patient
4. Patients suffering from: Diabetes mellitus, Hypertension
5. Pregnant and Lactating women
|
|
|
Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
To evaluate the efficacy of Marham-e-Safeda Kafoori in the management of Nar Farsi Talluqi (Contact Eczema)
To evaluate safety of Marham-e-Safeda Kafoori in the management of Nar Farsi Talluqi (Contact Eczema) |
at baseline, 7th, 14th, 21st, 28th, 35th and 42th day
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Assessment of safety of the study drug |
at baseline, 7th, 14th, 21st, 28th, 35th and 42th day
|
|
|
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)
|
01/02/2018 |
| 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
|
None yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Nar Farsi (Eczema) is a
group of diseases that results in inflammation of the skin and characterized by
itchiness, red skin, and a rash. There are various forms of Nar
Farsi (Eczema). Nar Farsi T’alluqi (Contact Eczema)
is an inflammatory skin process caused by an exogenous agent or agents that
directly or indirectly injure the skin. Contact eczema results from a complex
interaction between external substances or contactant and skin. It accounts for
4% to 7% of all patients presenting to the dermatology clinics. It is
classified as irritant or allergic. In irritant contact dermatitis (ICD), this
injury is caused by an inherent characteristic of a compound –for example, a
concentrated acid or base. Agents that cause Allergic contact dermatitis (ACD)
induce an antigen-specific immune response. The clinical lesion of contact
Eczema may be acute (wet and edematous) or chronic (dry, thickened,
and scaly), depending on the persistence of the insult.
Irritant contact dermatitis (ICD) is defined as
a non immunological inflammatory reaction of the skin to external agents which
cause direct toxic injury. It is caused by substances like alkalis, acids,
organic solvents oxidants and reducing agent. Acute ICD is painful, associated
with burning, stinging or itching. Mild irritants cause erythema, dryness and
fissuring while strong irritants often cause oedema, blistering and ulceration.
Allergic contact dermatitis (ACD) occurs due to
a delayed type 4 cell-mediated immunity. A minimum of 8 days to 10 days are
needed after sensitization for clinical allergy to manifest. Once sensitisation
to an allergen occurs, it tends to persist throughout life. However, the degree
of sensitivity wanes with time unless repeated exposures occurs.
Allergic contact dermatitis may clinically
present acute after allergen exposure and initial sensitization or after
elicitation in a previously sensitized individual. Erythema, oedema, papules,
vesicles and oozing are the cardinal signs of acute onset of eczematous ACD. In
India the common sensitisers are plants specially parthenium hysterophorus,
nickel, chromium and paraphenylene diamine. Parthenium allergy manifests as air
born contact dermatitis affecting the face, including the eyelids neck and
flexures.
An enormous number of substances are capable of
causing allergic contect dermatitis. Nickel dermatitis is one of the commonest
examples-some 5 percent of women in the UK are said to be nickel sensitive.
Affected individuals cannot wear stainless-steel jewellery because of the
nickel in the steel and develop a rash beneath steel studs, clips and buckles.
Patients who are nickel sensitive may also react to dichromate and other
chromate salts.
The pathogenesis of
Contact Eczema is complex and still incompletely understood. In management of
Contact Eczema, topical steroids, immunosuppressant and bland emollients are in
use but they only suppress the symptoms and relapse is always there. The
specific measures include emollients as well as steroids. The topical and
systemic steroid can cause several side effects.
Due to the high prevalence and non availability of safe and effective
treatment, present study is being designed to Evaluate the Efficacy and
Safety of Marham-e-Safeda Kafoori in the
Management of Nar Farsi T’alluqi (Contact Eczema).
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