| CTRI Number |
CTRI/2024/11/076373 [Registered on: 08/11/2024] Trial Registered Prospectively |
| Last Modified On: |
25/10/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug Unani |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Research on effect of Unani Medicine in Eczema |
|
Scientific Title of Study
|
A Comparative Clinical Study on the Efficacy of Arq-e-Shahetra orally and Mazo with Sirka vs Mirch e Siyah wa Safed with Cows Ghee Locally in Nar-e-Farsi (Eczema). |
| 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 Syed Shuaib Pasha |
| Designation |
PG Scholar |
| Affiliation |
Government Unani Medical College and Hospital |
| Address |
Department of Amraz Jild Wa Tazeeniyat, Room no.8, Government Unani Medical College and Hospital
Dr. Siddaiah Puranik Road, Basaveshwaranagar, Bangalore 560079
Bangalore KARNATAKA 560079 India |
| Phone |
8105931313 |
| Fax |
|
| Email |
drsyedshuaib@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Mohammed Asif Siddiqui |
| Designation |
Assistant professor |
| Affiliation |
Government Unani Medical College and Hospital |
| Address |
Department of Amraz Jild Wa Tazeeniyat, Room no.8, Government Unani Medical College and Hospital
Dr. Siddaiah Puranik Road, Basaveshwaranagar, Bangalore 560079
Bangalore KARNATAKA 560079 India |
| Phone |
9986812499 |
| Fax |
|
| Email |
drasif.i.siddiqui@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Mohammed Asif Siddiqui |
| Designation |
Assistant professor |
| Affiliation |
Government Unani Medical College and Hospital |
| Address |
Department of Amraz Jild Wa Tazeeniyat, Room no.8, Government Unani Medical College and Hospital
Dr. Siddaiah Puranik Road, Basaveshwaranagar, Bangalore 560079
Bangalore KARNATAKA 560079 India |
| Phone |
9986812499 |
| Fax |
|
| Email |
drasif.i.siddiqui@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government Unani Medical College & Hospital Bangalore-560079, Karnataka, India |
|
|
Primary Sponsor
|
| Name |
Government Unani Medical College & Hospital Bangalore-560079 |
| Address |
Government Unani Medical College and Hospital Dr Siddaiah
Puranik Road, Basaveshwaranagar Bangalore-560079
|
| Type of Sponsor |
Government medical college |
|
|
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 Syed Shuaib Pasha |
Government Unani Medical College and Hospital |
Department of Amraz Jild Wa Tazeeniyat, Room no.8,
Dr. Siddaiah Puranik Road, Basaveshwaranagar, Bangalore 560079
Bangalore KARNATAKA |
8105931313
drsyedshuaib@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee (IEC) for Biomedical research, Government Unani Medical College and Hospital, Bangalore. |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: L309||Dermatitis, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Shahetra (Fumariya Parviflora Lam) orally and Mazo (Quercus Infectoria Oliv) with sirka locally. |
Arq e Shahetra will be procured from Market.30 ml of Arq will be given before breakfast and dinner daily orally for 45 days.
Mazo will be powdered and mixed with Sirka and zimaad will be prepared and applied on lesions. |
| Comparator Agent |
Shahetra (Fumariya Parviflora Lam) orally and Safed Mirch (Piper Nigrum Linn), Siyah Mirch (Piper Nigrum Linn)and Cow Ghee Clarified Butter locally. |
Arq e Shahetra will be procured from Market.30 ml of Arq will be given before breakfast and dinner daily orally for 45 days.
Safed and Siyah Mirch will be powdered and mixed with Cow Ghee and Zimaad will be prepared and applied on lesions.
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients of age group between age 18 - 60 years
Patients of both genders
Clinically diagnosed patients of eczema as per Hanifin and Rajika criteria
Eczema of mild to moderate as per EASI score (≤29%)
History of Eczema less than 5 Years
|
|
| ExclusionCriteria |
| Details |
Patients with other skin diseases like psoriasis, lichen planus and active acute infections
Patients with diabetes , sys Htn , malignancy , autoimmune and other systemic diseases
Pregnant and lactating women
Patients not willing to attend treatment schedule regularly
|
|
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Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
• Decrease in Eczema Area and Severity Index (EASI) score.
• Change in photographs of the lesion
|
0TH Day,15th Day,30th Day 45th Day of study. post
follow up on 60th day.
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| •Decrease in Patient Oriented Eczema Measures (POEM) Questionnaire |
0TH Day,15th Day,30th Day 45th Day of study. post
follow up on 60th day.
|
|
|
Target Sample Size
|
Total Sample Size="36" Sample Size from India="36"
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)
|
10/11/2024 |
| 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="1" Months="6" 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 - NO
|
|
Brief Summary
|
Eczema (Nar-e-Farsi) is a inflammatory skin condition, characterized by dry skin with itchy patches which typically flactuates between periods of remission and flares. According to Ibn Abi Sadique Nar-e-Farsi is named because Naar means Aag as a patient feel more irritation and burning sensation in those lesions, Farsi means it was more common among the people of Mulk Faras( Persia) or referred to the physician who treated Nar-e-Farsi first also was a resident of Mulk Faras(Persia). M H Qamri described Nar-e-Farsi as a type of itch related to very severe non bearable burning , it occurs in some organs with vesiculation and the vesicles are filled with Raqeeq Rutubat (Thin fluid), which is due to increase of Hiddat in Khilt e Dam.Akbar Arzani also described Nar-e-Farsi as a skin disease associated with vesicle formation , itching and burning.Nar-e-Farsi is a type of disease which occurs due to alteration in humors and specially Lateef Safravi Mawaad (light yellow bile) which are eliminated towards the skin and appear in the form of vesicles with severe itching and burning . Along with safra some ghaleez mawaad is also accumulated which is responsible for itching, burning and chronicity of disease and Lateef Mawad is responsible for burning superficially .Eczema are classified into 3 groups based on etiology. Endogenous Eczema : Constitutional factors predispose the patient to develop an eczema. Eg : Nummular dermatitis. Exogenous Eczema : External stimuli triggers development of Eczema. Eg : Irritant dermatitis. Combined Eczema : when a combination of constitutional factors and extrinsic triggers are responsible for the development of eczema. Eg : Atopic Dermatitis. Clinical features of eczema are divided into 3 stages . Acute eczema is characterized by intense pruritus ,erythema, oedema , papules , vesicles , oozing ,crusting and even blister formation. In subacute Eczema there is diffused erythema, oedema, and scaling in this stage oedema, vesiculation and oozing components come down and lesion starts scaling. Chronic Eczema presents with severe pruritus, erythema, oedema, hyperkeratosis and lichenification.The signs and symptoms of Eczema are assessed on the basis of eczema area and severity index EASI score and patient oriented eczema measure POEM questionnair. This is more feasible in obtaining a quick and simple understanding of severity of disease and response to medication. A study recommends using EASI score with POEM Questionnaire to assess objective and subjective disease severity measurement. In Unani system of medicine ,management of Nar-e-Farsi depends on various factors like environment, lifestyle, diet and family history of patient. First and foremost predisposing and aggrevating factors should be eliminated, suitable changes in lifestyle and diet to be done and istefragh by means of Fasd and correction of the Sue Mizaj is recommended. Drugs possessing properties like Musaffi e Dam(blood purifier),Mujaffif(desiccative), Musakkin(soothing), Mubarrid(coolent), Muhallil(resolvant) are indicated for the treatment of Nar-e Farsi like Ushba , Shahetra , Sandal Safaid ,Chiraita ,Mundi ,Chobchini, Bisfaij , Kafoor , Raal , Kat Safaid , Gil-e-Armani , Mazo . Based on above properties a Unani formulation of Arq-e-Shahetra orally and Zimaad of Mazo with Sirka and Mirch e Siyah wa Safed with Cows Ghee locally are selected to evaluate there efficacy in Nar-e- Farsi. |