| CTRI Number |
CTRI/2021/07/034815 [Registered on: 13/07/2021] Trial Registered Prospectively |
| Last Modified On: |
09/07/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Medical Device
Unani |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effect of Leech Therapy and Herbal Ointment in Psoriasis |
|
Scientific Title of Study
|
Efficacy of Irsal-i-Alaq (Leech Therapy) and Zimad (Paste) in Taqashshur-i-Jild (Psoriasis): A Comparative Randomised Clinical Trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Umme Ayman |
| Designation |
PG SCHOLAR |
| Affiliation |
National Institute of Unani Medicine |
| Address |
Department of ILAJ BIT TADBEER National Institute Of Unani Medicine, Kottigepalya, Magadi Main Road, Bangalore
No. 248, 9th Cross, JHBCS Layout, Banashankari 2nd Stage, Bangalore 560078
Bangalore
KARNATAKA
560091
India |
| Phone |
9886740303 |
| Fax |
|
| Email |
ayman161093@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Mohd Nayab |
| Designation |
Assistant Professor |
| Affiliation |
National Institute of Unani Medicine |
| Address |
Department of ILAJ BIT TADBEER National Institute of Unani Medicine, Kottigepalya, Magadi main road, Bangalore
KARNATAKA
560091
INDIA
Bangalore
KARNATAKA
560091
India |
| Phone |
9019080556 |
| Fax |
|
| Email |
nayabdr@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Mohd Nayab |
| Designation |
Assistant Professor |
| Affiliation |
National Institute of Unani Medicine |
| Address |
Department of ILAJ BIT TADBEER National Institute of Unani Medicine, Kottigepalya, Magadi main road, Bangalore
KARNATAKA
560091
INDIA
Bangalore
KARNATAKA
560091
India |
| Phone |
9019080556 |
| Fax |
|
| Email |
nayabdr@gmail.com |
|
|
Source of Monetary or Material Support
|
| National Institute of Unani Medicine, Kottigepalya, Magadi main road, Bangalore-560091 |
|
|
Primary Sponsor
|
| Name |
National Institute of Unani Medicine |
| Address |
National Institute of Unani Medicine, Kottigepalya, Magadi main road, Bangalore-560091 |
| 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 |
| Dr Mohd Nayab |
National Institute of Unani Medicine |
Room number 28, Department of Ilaj-bit-Tadbeer
Bangalore
KARNATAKA |
9019080556
nayabdr@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, NIUM |
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 |
| Intervention |
Leech Therapy and Zimad (Paste) application |
Two sittings of Leech Therapy per week will be done for 35 days along with Zimad (Paste) application twice daily for 35 days. |
| Comparator Agent |
Zimad (Paste) application |
Zimad (Paste) will be applied twice daily for 35 days. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Clinically diagnosed patients of Taqashshur-i-Jild
2. Willingness to participate in the study and follow the instructions |
|
| ExclusionCriteria |
| Details |
1. Uncontrolled Diabetes mellitus with RBS > 250 mg/dl
2. Hypotensive patient with BP <100/60mmHg
3. Bleeding disorders
4. Anaemia with Hb <10gm%
5. Acute infection and septicaemia
6. Patients on concomitant therapy
7. Immuno-compromised patients
8. Pregnant and lactating women
9. Other systemic disorders
10.Patients on blood thinking agents |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Evaluation for prognosis with averaged PASI |
On 0 Day, 21st Day and 35th Day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Dermatological Life Quality Index (DLQI)
2. Changes in the photographs of the affected site in fixed location and controlled illumination |
On 0 Day, 21st Day and 35th Day |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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)
|
15/07/2021 |
| 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)?
Response - NO
|
|
Brief Summary
|
Psoriasis is a
chronic, inflammatory, hyperproliferative skin disease, characterized by
well-defined erythematous scaly plaques particularly affecting the extensor
surfaces and scalp. It usually follows a relapsing and remitting course.
Its management is
unsatisfactory in conventional science. The drugs commonly employed for
systemic therapy are corticosteroids, Methotrexate, Retinoids and Cyclosporins
etc. Systemic medication carries a potential for more serious side effects than
the topical therapy. Long term use of topical steroids causes dermal atrophy,
tachyphylaxis and rarely adrenal suppression.
Unani Physicians
mentioned a wide range of treatment for Amraz-i-Jild including
Taqashshur-i-Jild and are treating the condition since a long time without much
serious side effects. The claims of Unani physicians should be validated on
authentic modern scientific parameters for worldwide acceptance. Keeping these
facts in mind, this study is designed to evaluate the efficacy of Irsal-i-Alaq
(Leech Therapy) and Zimad (Paste) in Taqashshur-i-Jild (Psoriasis).
|