| CTRI Number |
CTRI/2024/02/062979 [Registered on: 21/02/2024] Trial Registered Prospectively |
| Last Modified On: |
09/01/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug Unani |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Evaluation of efficacy and safety of Polyherbal Unani formulations in the management of Eczema |
|
Scientific Title of Study
|
Evaluation of efficacy and safety of Polyherbal Unani formulations, ItrÄ«fal Shahtara orally and Marham Kharish Jadeed topically in the management of NÄr FÄrsÄ« (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 |
Madiha Akhtar |
| Designation |
MD Scholar |
| Affiliation |
Hakim Syed Ziaul Hasan Government Unani Medical College and Hospital |
| Address |
Hakim Syed Ziaul Hasan Government Unani Medical College and Hospital Ayush Campus kolar Bypass Road Bhopal Madhya Pradesh
Bhopal MADHYA PRADESH 462003 India |
| Phone |
9958904901 |
| Fax |
|
| Email |
madihaakhtar23@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Munawwar Gauri |
| Designation |
Assistant professor |
| Affiliation |
Hakim Syed Ziaul Hasan Government Unani Medical College and Hospital |
| Address |
Department of Amraze Jild wa Tazeeniyat ,Hakim Syed Ziaul Hasan Government Unani Medical College and Hospital Ayush Campus kolar Bypass Road Bhopal Madhya Pradesh
Bhopal MADHYA PRADESH 462003 India |
| Phone |
9981817255 |
| Fax |
|
| Email |
mgauri52@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Munawwar Gauri |
| Designation |
Assistant professor |
| Affiliation |
Hakim Syed Ziaul Hasan Government Unani Medical College and Hospital |
| Address |
Department of Amraze Jild wa Tazeeniyat ,Hakim Syed Ziaul Hasan Government Unani Medical College and Hospital Ayush Campus kolar Bypass Road Bhopal Madhya Pradesh
Bhopal MADHYA PRADESH 462003 India |
| Phone |
9981817255 |
| Fax |
|
| Email |
mgauri52@gmail.com |
|
|
Source of Monetary or Material Support
|
| Hakim Syed Ziaul Hasan Government Unani Medical College and Hospital and Madhya Pradesh Medical Science University Jabalpur |
|
|
Primary Sponsor
|
| Name |
Hakim Syed Ziaul Hasan Government Unani Medical College and Hospital Ayush |
| Address |
Hakim Syed Ziaul Hasan Government Unani Medical College and Hospital Ayush Campus kolar Bypass Road Bhopal Madhya Pradesh |
| 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 |
| Madiha Akhtar |
Hakim Syed Ziaul Hasan Government Unani Medical College and Hospital |
OPD No.5 Department of Amraze Jild wa Tazeeniyat Hakim Syed Ziaul Hasan Government Unani Medical College and Hospital Ayush Campus kolar Bypass Road Bhopal Madhya Pradesh Bhopal MADHYA PRADESH |
9958904901
madihaakhtar23@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committe Hakim Syed Ziaul Hasan Government Unani Medical College and Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: L20-L30||Dermatitis and eczema, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Betamethasone Valerate 0.1% cream |
Betamethasone Valerate 0.1% cream is to be applied as athin layer on the affected part twice daily for 6 weeks. |
| Intervention |
Itrifal Shahtara and Marham Kharish Jadeed |
Itrifal Shahtara is to be taken 10 grams with water at bed time daily for 6 weeks and Marham Kharish jadeed is to be applied as a thin layer on the affected part twice daily for 6 weeks. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Patients who are willing and able to comply with the scheduled visits and treatment plan, laboratory testing and other study procedure and capable of providing a signed informed consent form indicating the subject has been informed of all pertinent aspects of the study. |
|
| ExclusionCriteria |
| Details |
1.Patients with an evidence of clinically significant and uncontrolled systemic illness.
2.Patients with a current diagnosis of active skin disease (e.g., psoriasis, lupus erythematosus) or skin infection (bacterial, fungal or viral) especially in place of eczema at the same time.
3. Patients who had been using topical steroids within past 14 days.
4. Pregnant and lactating women.
5. Patients who have a known history or clinically relevant allergy, in particular to any component of the study treatment.
6. Patients unlikely to cooperate with the study protocol. |
|
|
Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.POEM (Patient Oriented Eczema Measure)
2. EASI (Eczema Area and Severity Index) Score
3. Pruritus NRS Assessment |
Baseline, 2nd week ,4th week and 6th week |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| DLQI ( Dermatology Life Quality Index |
Baseline & 6th week |
|
|
Target Sample Size
|
Total Sample Size="44" Sample Size from India="44"
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)
|
01/03/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
01/03/2024 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1" 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 - NO
|
|
Brief Summary
|
Eczema is an inflammatory skin condition clinically characterized by erythema, papules, scaling, vesicles, fissures, hyperkeratosis and symptoms such as itch and pain. Over the span of 2009 – 2019, the highest prevalence of Atopic dermatitis was noted among Swedish children with 34%. In India, point prevalence of Atopic dermatitis is 6.75% and that in older individuals was 11.4% . Eczema can affect patient’s quality of life by causing emotional and physical distress, increased anxiety or social avoidance because of a continuous fear of being negatively judged, sleep deprivation, low self-esteem and even disability in more severe cases diminishing their occupational options. In conventional system of medicine, the main treatment includes emollients and topical steroids whose prolonged use causes adverse effects like atrophy, striae, rosacea, telangiectasia, rebound dermatitis along with resistance, early ageing and various toxicities or allergies to preservatives in topical creams . Keeping in view the adverse effects and limitations of conventional system of medicine along with an impaired quality of life, there is an imperative need to explore better treatment options. Unani system of Medicine is an ancient, time tested medicine with a rich literature of dermatology in which renowned physicians have elaborately mentioned and successfully treated various skin disorders. In order to treat eczema, ta’adil-e-khilt (normalization of causative humour), mubarridat (coolants), murattibat (humectants) , Musaffi-i-Dam (blood purifiers) etc. were used by them. So, in order to transform the diversity of knowledge mentioned in the literature into valid evidences and for better documentation, this study has been conceived. |