| CTRI Number |
CTRI/2025/03/081912 [Registered on: 07/03/2025] Trial Registered Prospectively |
| Last Modified On: |
07/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Unani
Preventive |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Study on the Safety and Effectiveness of Safuf-i-Musaffi Khas and Ravghan-i-Hina for Treating Psoriasis |
|
Scientific Title of Study
|
A Randomized, Parallel Group, Open Label, Active Controlled Clinical Study to evaluate the Safety and Efficacy of Safuf-i-musaffi khas and Ravghan-i-Hina in the Management of Taqashshur al-Jild(Psoriasis) |
| 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 WALIULLAH |
| Designation |
PG SCHOLAR |
| Affiliation |
National Research Institute of Unani Medicine for Skin Disorders |
| Address |
Department of Moalajat (Medicine), National Research Institute of Unani Medicine for Skin Disorders (Formerly Central Research Institute of Unani Medicine) Hyderabad
Hyderabad
TELANGANA
500038
India |
| Phone |
8979561160 |
| Fax |
|
| Email |
waliullahkhan803@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR SHAIK MOHAMMED HUSSAIN |
| Designation |
Lecturer, Department of Moalajat (Medicine) |
| Affiliation |
National Research Institute of Unani Medicine for Skin Disorders |
| Address |
Department of Moalajat (Medicine), National Research Institute of Unani Medicine for Skin Disorders (Formerly Central Research Institute of Unani Medicine) Hyderabad
Hyderabad
TELANGANA
500038
India |
| Phone |
7989789310 |
| Fax |
|
| Email |
drmdhussainshaikh143@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR WALIULLAH |
| Designation |
PG SCHOLAR |
| Affiliation |
National Research Institute of Unani Medicine for Skin Disorders |
| Address |
Department of Moalajat (Medicine), National Research Institute of Unani Medicine for Skin Disorders (Formerly Central Research Institute of Unani Medicine) Hyderabad
Hyderabad
TELANGANA
500038
India |
| Phone |
8979561160 |
| Fax |
|
| Email |
waliullahkhan803@gmail.com |
|
|
Source of Monetary or Material Support
|
| National Research Institute of Unani Medicine for Skin Disorders (NRIUMSD), Hyderabad |
|
|
Primary Sponsor
|
| Name |
National Research Institute of Unani Medicine for Skin Disorders, Hyderabad |
| Address |
8-3-168/A/1/UM, A. G. Colony Road, ESI Metro Station, Erragadda, Hyderabad - 500038 |
| 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 WALIULLAH |
National Research Institute of Unani Medicine for Skin Disorders |
OPD & IPD Department of Moalajat (Medicine), National Research Institute of Unani Medicine for Skin Disorders (Formerly Central Research Institute of Unani Medicine), 8-3-168/A/1/UM, A.G Colony Road, ESI Metro Station, Erragadda, Hyderabad - 500038
Hyderabad
TELANGANA |
8979561160
waliullahkhan803@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, NRIUMSD, Hyderabad |
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 |
1. Psoralen: 8 Methoxsalen (MOP)
2. Petroleum Jelly |
1. Psoralen: 8 Methoxsalen (MOP), Dose: 0.6 mg/kg on alternate days after breakfast, Dosage Form: Tablets (Solid), Mode of administration: To be taken orally
2. All patients are also advised to apply Petroleum jelly twice daily, Dose: Q.S (Quantum Sufficit), Mode of Application: Topical |
| Intervention |
1. Safuf-i-Musaffi Khas
2. Ravghan-i-Hina |
1. Safuf-i-Musaffi Khas: Dosage Form: Safuf(Powder), Dose: 5gm OD, Mode of administration: Oral, Composition of Safuf-i-Musaffi Khas: Aamla Khushk(Emblica officinalis Gaertn), Waj-e-Turki(Bachh)(Acorus calamus Linn), Balela (Post Bahera)(Terminalia bellerica Roxb.), Post Darakht-e-Neem(Azadirachta indica A. Juss.), Post Halela Zard(Terminalia chebula Retz.), Dar-e-Hald(Berberis aristata Dc.), Kutki (Picrorhiza kurroa Royle ex. Benth), Gilo Khushk(Tinospora cordifolia (Willd) Miers.), Majeeth(Rubia cordifolia Linn.)
2. Ravghan-i-Hina: Dosage Form: Ravghan(oil), Dose: Q.S, Mode of administration: Local(Topical), Composition of Ravghan-i-Hina: Barg-e-Hina(Lawsonia inermis Linn.), Aab-e-Taaza(Freshwater), Ravghan-i-Kunjad(Sesamum indicum Linn.) |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
The participants will be included in the study on the basis of the following criteria:
1. Participants of any sex aged between 18 to 60 years.
2. Patients clinically diagnosed with Taqashshur al-Jild (Psoriasis).
3. Patients with a Psoriasis Area and Severity Index (PASI) score equal to or more than 10%.
4. Patients with a minimum psoriasis duration of at least six months.
5. Patients who have failed or are intolerant to at least one conventional systemic therapy for psoriasis.
6. Patients with a Dermatology Life Quality Index (DLQI) score more than 10.
7. Participants willing to provide written informed consent and comply with study procedures. |
|
| ExclusionCriteria |
| Details |
The following patients will be excluded:
1. Participants aged below 18 years or above 60 years.
2. Known cases of significant pulmonary, cardiovascular, hepatic, renal dysfunction, malignancy, HIV/AIDS, or other systemic diseases.
3. Pregnant or lactating women.
4. Patients unwilling to attend the clinical trial.
5. Patients with other skin conditions, such as eczema or chronic dermatitis, that could interfere with psoriasis assessment.
6. Patients currently taking medications that interfere with study drug metabolism or psoriasis severity.
7. Patients with a history of alcohol or drug abuse.
8. Patients with uncontrolled psychiatric disorders.
9. Patients with known hypersensitivity to any component of the study medications. |
|
|
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 |
| Clinical assessment will be done at baseline visit and at each follow-up visit 2nd, 4th and 8th weeks and the assessment of response to treatment will be made on the basis of the change in PASI Score after 8th weeks of therapy. For the efficacy of the test drug, 25% change in appearance and symptomatic relief will be considered significant. |
8 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Photographic Assessment: Digital photography of all lesions will be done using conditions (fixed room, fixed lighting & fixed camera settings) at baseline & 8th week. |
8 weeks |
| Improvement in DLQI from baseline |
8 weeks |
| Improvement in IGA from baseline |
8 weeks |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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/ Phase 3 |
|
Date of First Enrollment (India)
|
01/06/2025 |
| 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="8"
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
|
Psoriasis is a chronic inflammatory skin disease affecting 0.44-2.8% of the Indian population, often manifesting in the third or fourth decade of life. Conventional treatments, such as corticosteroids and phototherapy, pose risks including hepatotoxicity, phototoxicity, and relapse. Unani medicine, with holistic approaches, offers safer alternatives. This randomized, parallel-group, open-label, active-controlled clinical study aims to evaluate the safety and efficacy of Safuf-i-Musaffi Khas and Ravghan-i-Hina in treating Taqashshur al-Jild (Psoriasis). Eligible participants will be randomized to either the test or control groups. Baseline and post-treatment laboratory investigations will be conducted. The study duration is 8 weeks, with an estimated total sample size of 60 participants. |