| CTRI Number |
CTRI/2025/09/094698 [Registered on: 12/09/2025] Trial Registered Prospectively |
| Last Modified On: |
18/02/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug Unani |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
UNANI TREATMENT FOR HAND AND FOOT PSORIASIS |
|
Scientific Title of Study
|
Efficacy of Joshanda Aftimoon orally with Zimad Kundush and shahed vs Latukh of Arad Adas and Gule Surkh in Palmoplantar psoriasis-A Randomised Comparative Clinical Trial |
| 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 Masiha Banu |
| Designation |
PG Scholar |
| Affiliation |
Government Unani Medical College And Hospital |
| Address |
Department of Amraze Jild Wa Tazeeniyat Room no 8 Government Unani Medical College And Hospital
Dr Siddaiah Puranik Road
Basaveshwaranagar
Bengalore
Bangalore KARNATAKA 560079 India |
| Phone |
9945745580 |
| Fax |
|
| Email |
maseehabanu303@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Mohammed Asif Siddiqi |
| Designation |
Assistant professor |
| Affiliation |
Government Unani Medical College And Hospital |
| Address |
Department of Amraze Jild wa Tazeeniyat Room no 8 Government Unani Medical College and Hospital
Dr Siddaiah Puranik Road Basaveshwaranagar Bangalore
Bangalore KARNATAKA 560079 India |
| Phone |
919986812499 |
| Fax |
|
| Email |
drasif.i.siddiqui@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Mohammed Asif Siddiqi |
| Designation |
Assistant professor |
| Affiliation |
Government Unani Medical College And Hospital |
| Address |
Department of Amraze Jild wa Tazeeniyat Room no 8 Government Unani Medical College and Hospital
Dr Siddaiah Puranik Road Basaveshwaranagar Bangalore
Bangalore KARNATAKA 560079 India |
| Phone |
919986812499 |
| Fax |
|
| Email |
drasif.i.siddiqui@gmail.com |
|
|
Source of Monetary or Material Support
|
| OPD 8 Government Unani Medical College and Hospital Bangaluru 560079 |
|
|
Primary Sponsor
|
| Name |
Government Unani Medical And Hospital |
| Address |
Dr Siddaiah Puranika Road
Basaveshwaranagar
Bengaluru 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 Masiha Banu |
Govt Unanai Medical College and Hospital |
Opd 8 Govt Unanai Medical College and Hospital Siddiah Puranik Road Basaveshwaranagar Bengaluru 560079 Bangalore KARNATAKA |
9945745580
maseehabanu303@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: L403||Pustulosis palmaris et plantaris, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Aftimoon Cuscuta reflexa Roxb Orally and Arad Adas Lens esculenta Roxb with Gule Surkh Rosa damascene Mill locally |
Joshanda decoction is prepared by boiling 5gm of Aftimoon which is soaked overnight in 100ml of water till water reduces to half of its volume 50ml then filter it 50ml of Joshända Aftimoon will be administered orally before breakfast daily for 30 days and Required quantity of Arad Adas and Gule Surkh will be powdered and mixed with water Clean the affected areas and apply the required quantity of Latukh daily at night and washed in morning with water for 30 days |
| Intervention |
Aftimoon Cuscuta reflexa Roxb Orally and Kundush Pueraria montana with Shahed locally |
Joshanda decoction is prepared by boiling 5gm of Aftimoon which is soaked overnight in 100ml of water till water reduces to half of its volume 50ml then filter it 50ml of Joshända Aftimoon will be administered orally before breakfast daily for 30 days and Required quantity of Kundush will be powdered and mixed with Shahed Clean the affected areas and apply the required quantity of Zimad daily at night and washed in morning with water for 30days |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
Clinically diagnosed cases of Palmoplantar Psoriasis
10-30 percent of area involved in one or both palms and soles as per m-PPPASI |
|
| ExclusionCriteria |
| Details |
Patients with uncontrolled DM and HTN
Immunocompromised Patients
Pregnant and Lactating Women
History of treatment for psoriasis including PUVA Therapy and systemic steroids in past one month
Patients suffering from HIV Impetigo Herpes zoster Eczema or any Fungal infections |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reduction in m-PPPASI score |
0thday 10thday 20thday 30thday |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Photographic changes |
0thday and 30thday |
|
|
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)
|
25/11/2025 |
| 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="6" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
Publication Details
Modification(s)
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Psoriasis is a common genetically determined inflammatory skin disorder of unknown cause which in its most usual form is characterized by well demarcated raised red scaling patches that preferentially localize to the extensor surfaces
Most common sites of involvement are scalp elbow and knees hands feet trunk and nails Palmoplantar Psoriasis can occur alone on palms and soles or along with involvement of the other areas
It affects around 2 to 3 percent of the world population In India it affects about 0.8 to 8 percent population Among the types of Psoriasis prevalence of Palmoplantar Psoriasis is about 2.8 to 40.9 percent in psoriatic patients Psoriasis usually affects the age group between 15 to 50 years and less common below 10 years of age
In conventional medicine mild psoriasis is treated by topical application of emollients topical corticosteroids calcipotriene tazarotene topical tars anthralin and keratolytics
Mild psoriasis requires phototherapy or systemic therapy in combination with topical agents or phototherapy Systemic therapy includes Methotrexate Photo chemotherapy Narrow band UVB therapy Retinoids and Cyclosporine Biologics used for moderate to severe Psoriasis include Etanercept Alefacept Efalizumab Infliximab and Adalimumab And it is reserved for the patient who fail or cannot complete treatment with topical or systemic medications But these drugs exert adverse effects such as nausea dryness of mouth fatigue alopecia nephrotoxicity hepatotoxicity teratogenicity hypertension drug interaction In Unani medicine the principle of treatment for Palmoplantar Psoriasis include Istefragh i Sawda and Mukhrij e Sawda Single drugs such as Afsantheen Aftimoon Halela Mundi Ushba Shoniz and Compound formulations such as Ayarijat and Maul jubn are used
However these drugs have not been scientifically explored so far Thus the present study entitled Efficacy of Joshanda Aftimoon orally along with Zimad Kundush and Shehad vs Latukh of Arad Adas and Gule Surkh in Palmoplantar Psoriasis A Randomized Comparative Clinical Trial is designed to provide safe more effective and economical treatment for Palmoplantar Psoriasis |