| CTRI Number |
CTRI/2020/07/026420 [Registered on: 07/07/2020] Trial Registered Prospectively |
| Last Modified On: |
06/07/2020 |
| 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
|
Clinical Study Of unani formulation and betamethsone in the treatment of Psoriasis. |
|
Scientific Title of Study
|
Clinical study of Taqashshur-al-jild (psoriasis) with Therapeutic evaluation of Unani drugs Aftimoon (Cuscuta reflexa) with Ma ul Jubn (whey) as Joshanda (Decoction) and Magh Tukhmi Kharpaza (seed of kernel of musk melon) along with Gule Baboona (Matriucccaria chamomillia) as Zimad (paste) in its Management |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Tariq Rahi |
| Designation |
PG Scholar |
| Affiliation |
Regional Research institute of Unani Medicne University of Kashmir ,Srinagar |
| Address |
Deptt Of Moalajat Room No.102 Ground Floor RRIUM,Naseem Bagh Campus Kashmir University ,Hazratbal,Srinagar.
Srinagar
JAMMU & KASHMIR
190006
India |
| Phone |
9906770278 |
| Fax |
|
| Email |
rahitariq2013@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Professor Naquibul Islam |
| Designation |
Professor |
| Affiliation |
Regional Research Institute of Unani Medicine |
| Address |
Deptt.of Moalajat,Room No.108 Ground Floor RRIUM,Naseem Bagh Campus Kashmir University,Hazratbal,
Srinagar
Srinagar
JAMMU & KASHMIR
190006
India |
| Phone |
9469154930 |
| Fax |
|
| Email |
naquibislam@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Towseef Amin Rafeeqi |
| Designation |
Research Officer Biochemistry |
| Affiliation |
Regional Research Institute of Unani Medicine |
| Address |
Deptt. Of Biochemistry Room No.109 Ground Floor RRIUM,Naseem Bagh Campus,Kashmir University
Srinagar
Srinagar
JAMMU & KASHMIR
190006
India |
| Phone |
9419998380 |
| Fax |
|
| Email |
towseef@gmail.com |
|
|
Source of Monetary or Material Support
|
| Central Council For Research in Unani Medicine. Regional Research Institute Of Unani Medicine ,Naseem Bagh Campus ,Kashmir University Hazratbal
Srinagar |
|
|
Primary Sponsor
|
| Name |
central counsal for research in unani medicine new delhi |
| Address |
new delhi |
| Type of Sponsor |
Contract research organization |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| NIL |
NIL |
| Regional Research Institute Of Unani Medicine Naseem Bagh Campus University Of Kashmir Srinagar |
university of kashmir srinagar |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| dr tariq rahi |
regional research institute of unani medicine naseem bagh campus kashmir university srinagar |
Moalajat OPD-2
RRIUM,
Naseem Bagh Campus,
Kashmir University,
Shazratbal,
Srinagar,
Jammu and Kashmir,
India,
190006
Srinagar
JAMMU & KASHMIR |
9906770278
rahitariq2013@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: L409||Psoriasis, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Betamethasone valerate 1% cream |
Mode Of application:Topical,
Dose:QS for the affected area,
Frequency:Twice daily.
Duration Of the Protocol therapy:90 days |
| Intervention |
decoction of aftimoon 5gm morninig and 5gm evevning with Ma ul jbn 170 ml morning and evening and locally paste of magz tukhm kharpaza and gule baboona in equal quantity. |
Mode Of application: 1.Decoction to be used orally,
Dose:5gm twice a day along with whey liquid 170ml twice a day,
Frequency: twice daily.
Duration Of protocol therapy:90 days.
2. Topical Treatment.
Mode of application:Topical,
Dose:QS for the affected area,
Frequency:Twice daily,
Duration Of the Protocol Therapy:90 days. |
|
|
Inclusion Criteria
|
| Age From |
10.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Clinically Diagnosed Patients of Psoriasis.
Patients irrespective of gender.
Patients in the age group of 10-60 years.
Clinically stable patients.
Patients who have agreed to sign the informed consent form and follow up the protocol. |
|
| ExclusionCriteria |
| Details |
Subjects below the age group of 10 and above the age of 60 years.
Patients suffering from from other concomitant disorders like Dermatophytes,Eczema ,Seborrhic Dermatitis,Pityriasis Rosea.
Patients with systemic diseases like diabetes,malignancy.
patients who refuse to give written consent for the study.
pregnant and lactating women.
any of them not covered under inclusion criteria. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| relief in signs and symptoms of psoriasis |
6-12 Weeks. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| not applicable |
not applicable |
|
|
Target Sample Size
|
Total Sample Size="52"
Sample Size from India="52"
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)
|
09/07/2020 |
| 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="0"
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
|
Taqashshur -e -jild (psoriasis) comes within the heading of papulosqumous dermatosis and is chronically recurring disease. This is a non infectious inflammatory, genetically predisposed autoimmune disorder characterized by well defined erythematous plaques bearing large adherent silvery scales. The disease affects 1% to 3% of world population and some authors have mentioned 1% to 11% . In India it varies from 0.84% to 5.6% in different studies. In classical Unani text books psoriasis has been named under the heading of Taqashshur-e- jild on the basis of humoural theory according to them, excessive amount of khilt-e- ghaleez(abnormal sauda) accumulates under the skin and hampers its nutrition and function, due to which skin becomes dry and dead and fall out in the form of scales.
|