| CTRI Number |
CTRI/2025/08/093913 [Registered on: 29/08/2025] Trial Registered Prospectively |
| Last Modified On: |
28/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug Medical Device Unani Diagnostic |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Evaluate the safety and efficacy of Oral and Local
Unani Formulations in the Management of Eczema |
|
Scientific Title of Study
|
Evaluation of the safety and efficacy of Sharbat Unnab and Topical
Unani formulation (Tila) in the management of Nar farsi(Eczema):
An open label randomized controlled study. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Nadeem Iqbal |
| 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 |
08896171194 |
| Fax |
|
| Email |
drnadeemiqbal5@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Mohammad Anzar Husain |
| Designation |
Professor and HOD |
| 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 |
7000097052 |
| Fax |
|
| Email |
mohdanzarhusain@yahoo.in |
|
Details of Contact Person Public Query
|
| Name |
Nadeem Iqbal |
| 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 |
08896171194 |
| Fax |
|
| Email |
drnadeemiqbal5@gmail.com |
|
|
Source of Monetary or Material Support
|
| Hakim Syed Ziaul Hasan Government Unani Medical College and Hospital Bhopal Madhya Pradesh Medical Science University Jabalpur Madhya Pradesh, India 462003 |
|
|
Primary Sponsor
|
| Name |
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 India
462003 |
| 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 Nadeem Iqbal |
Hakim Syed Ziaul Hasan Government Unani Medical College and Hospital |
OPD 5 ground floor 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 |
08896171194
drnadeemiqbal5@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee 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: L209||Atopic dermatitis, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Betamethasone valerate 0.1% cream |
Betamethasone valerate 0.1% cream is given to the patient, and is advised to apply a thin layer of the cream on the eczematous area twice daily for 42 days. |
| Intervention |
Sharbat Unnab and 5 Unani drugs composed in the form of a liniment(tila) |
Sharbat unnab 20 ml is to be taken by the patient twice daily after meals for 42 days.
a liniment(tila) is prepared from Safeda kashgari (soap stone), murdarsang (Plumbous oxide), sandal safaid (Santalum album), Kafoor ( Cinnamomum camphora) and Arq gulab (Rosa damascene) that is given to the patient and the patient is advised to apply a thin layer of it on the eczematous area twice daily for 42 days. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients willing to get enrolled in the study with informed consent & follow the protocol.
2. Diagnosed cases of eczema as per Hannifin and Rajka criteria.
3. Patients willing to attend treatment schedules regularly. |
|
| ExclusionCriteria |
| Details |
1. Pregnant or lactating women.
2. Diabetic patients.
3. History of unstable pulmonary /cardiovascular / hepato-renal dysfunction or any other serious comorbid condition & known cases of immunocompromised states like AIDS etc.
4.Patients not willing to attend treatment schedule regularly. |
|
|
Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Patient Oriented Eczema Measure (POEM)
|
At baseline , 14th , 28th and 42nd day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. SCORing Atopic Dermatitis (SCORAD)
2.Eczema Area Severity Index (EASI)
3. Dermatology Life Quality Index (DLQI) |
At baseline , 14th , 28th and 42nd day |
|
|
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)
|
08/09/2025 |
| 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="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, also known by the names of Nar farsi, Chajjan or
Akota in the Unani system of medicine. The word Nar farsi which means Intense
itching and burning was originally used in Persia, or the individual who used
it was from Persia. The Greek term ekzein which means to boil forth and effervescence
is where the word eczema first appeared in writing in AD 543. It can affect
anybody, regardless of age or gender and is clinically characterized by varying
degrees of clinical manifestations including dryness, erythema, excoriation,
exudation, fissuring, hyperkeratosis, lichenification, papulation, scaling and vesiculation.
In pediatric and adult studies, the prevalence of atopic dermatitis ranged from
0.98% to 9.2%. Eczema is a disabling condition that causes its sufferers to
have socioeconomic issues including insomnia, anxiety, personality disorders,
and difficulty carrying out everyday tasks. Patient’s quality of life is
diminished by this illness. Conventional treatment includes topical
corticosteroids to manage eczema and moisturizers or emollients to relieve dry
skin. Several adverse effects, including skin atrophy, hair loss, weight gain, nephrotoxicity,
hepatotoxicity, etc. have been linked to the use of systemic corticosteroids.
This leads us to look for alternative safe and effective option to treat Nar
farsi. Unani system of Medicine is very ancient and rich system of medicine.
Though the ancient Unani physicians successfully treated Nar farsi and
mentioned their experiences in Unani classical literature but their proper
documentations on the recent scientific parameters is yet to be done, in order
to convert these experiences into evidences to benefit the masses with
confidence. Keeping in view of the fact this study is designed to clinically
evaluate the safety and efficacy of an Unani ancient formulation on scientific
parameters. |