| CTRI Number |
CTRI/2025/09/094098 [Registered on: 02/09/2025] Trial Registered Prospectively |
| Last Modified On: |
02/09/2025 |
| 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
|
Evaluation of safety and
efficacy of Poly herbal formulations in the management of
Psoriasis |
|
Scientific Title of Study
|
A Randomized Controlled Trial (RCT) to Evaluate Safety and
Efficacy of Compound Unani Formulations Nuqooe Musaffi
Orally and Marhame Surkh Topically 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 |
Bushra Ansari |
| Designation |
PG Scholar |
| Affiliation |
Hakim Syed Zia ul Hasan Government Autonomous Unani Medical College and Hospital |
| Address |
Hakim Syed Zia ul Hasan Government Autonomous Unani Medical College and Hospital Ayush Campus Kolar Bypass Road Bhopal Madhya Pradesh 462003
Hakim Syed Ziaul Hasan Government Autonomous Unani Medical College and Hospital Ayush Campus Kolar Bypass Road Bhopal Madhya Pradesh 462003
Bhopal
MADHYA PRADESH
462003
India |
| Phone |
8319289134 |
| Fax |
|
| Email |
ansaribushra235@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Dilshad Ali |
| Designation |
Associate Professor |
| Affiliation |
Hakim Syed Zia ul Hasan Government Autonomous Unani Medical College and Hospital |
| Address |
Hakim Syed Zia ul Hasan Government Autonomous Unani Medical College and Hospital Ayush Campus Kolar Bypass Road Bhopal Madhya Pradesh 462003
Hakim Syed Ziaul Hasan Government Autonomous Unani Medical College and Hospital Ayush Campus Kolar Bypass Road Bhopal Madhya Pradesh 462003
MADHYA PRADESH
462003
India |
| Phone |
08319768281 |
| Fax |
|
| Email |
dilshadali28@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Bushra Ansari |
| Designation |
PG Scholar |
| Affiliation |
Hakim Syed Zia ul Hasan Government Autonomous Unani Medical College and Hospital |
| Address |
Hakim Syed Zia ul Hasan Government Autonomous Unani Medical College and Hospital Ayush Campus Kolar Bypass Road Bhopal Madhya Pradesh 462003
Hakim Syed Ziaul Hasan Government Autonomous Unani Medical College and Hospital Ayush Campus Kolar Bypass Road Bhopal Madhya Pradesh 462003
Bhopal
MADHYA PRADESH
462003
India |
| Phone |
8319289134 |
| Fax |
|
| Email |
ansaribushra235@gmail.com |
|
|
Source of Monetary or Material Support
|
| Hakim Syed Zia ul Hasan Government Autonomous Unani Medical College and Hospital Bhopal Madhya Pradesh Medical Science University Jabalpur Madhya Pradesh 482003 India |
|
|
Primary Sponsor
|
| Name |
Hakim Syed Zia ul Hasan Government Autonomous Unani Medical College and Hospital |
| Address |
Hakim Syed Zia ul Hasan Government Autonomous Unani Medical College and Hospital Ayush Campus Kolar Bypass Road Bhopal Madhya Pradesh 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 Bushra Ansari |
Hakim Syed Ziaul Hasan Government Autonomous Unani Medical College and Hospital |
OPD no 5 Department of Amraze Jild wa Tazeeniyat (Ground Floor) Hakim Syed Ziaul Hasan Government Autonomous Unani Medical College and Hospital Bhopal Madhya Pradesh
Bhopal
MADHYA PRADESH |
08319289134
ansaribushra235@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Hakim Syed Ziaul Hasan Government Autonomous Unani Medical College and Hospital |
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 0.1.% cream |
Betamethasone valerate 0.1% cream to be applied on the effected part twice a day for 42 days. |
| Intervention |
Orally Nuqooe Musaffi
along with local application of Marham Surkh which contains following ingredients 1. Murdarsang (Litharge)
2. Haldi (Curcuma longa)
3. Roghane zaitoon (Olea europaea oil)
4.Sirka angoori (Vinegar) |
For Nuqooe Musaffi patient is advised to soak mufrad unani herbs in sufficient water for 8 hrs/ overnight, and asked to take only the filterate in morning after filtering it with help of sieve and the Marham to be applied topically on the affected part twice a day in sufficient amount to cover skin lesions for 42 days |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Clinically diagnosed cases of psoriasis.
2. Patients with PASI Score less than 10.
6. Patients who are willing and able to comply with the protocol.
4. Patients who are willing and capable of providing a signed informed consent form. |
|
| ExclusionCriteria |
| Details |
1. Pregnant and lactating women.
2. Patients of pustular psoriasis, erytherodermic psoriasis and psoriatic arthritis.
3. Patients with history of local and systemic corticosteroids, immunosuppressive drugs and anti psoriatic systemic therapies during last 4 weeks.
4. Patients with uncontrollable significant diseases like DM,Hypertension, renal failure, hepatic failure and cardiac comorbidities.
5. Patients suffering from other concomitant skin diseases like vitiligo,eczema, lichen simplex and seborrheic dermatitis etc.
6. Patients concurrently participating in any other clinical trial. |
|
|
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. Psoriasis Area Severity Index (PASI)
2. Itching Visual Analogue Scale (VAS)
(On a 10 cm long horizontal scale) |
1. Psoriasis Area Severity Index (PASI) at Baseline and Final visit
2. Itching Visual Analogue Scale (VAS) at day 1,14,28,42 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Dermatology Life Quality Index (DLQI) |
On day 1,14,28,42 |
|
|
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)
|
15/09/2025 |
| 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 Yet Recruiting |
| 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
|
Taqashshur al Jild, Psoriasis is a chronic recurrent inflammatory skin disease characterized by sharply demarcated erythemato squamous plaques usually covered by silvery white scales. Common symptoms include itching and burning. Several clinical variants exist such as plaque type guttate erythrodermic inverse and pustular psoriasis. Globally the prevalence is between 2 and 3 while in India it ranges from 0.44 to 2.8 percent affecting males more frequently and typically appearing in the third or fourth decade of life. The etiology is multifactorial involving genetic immunological and environmental factors. Psoriasis is also associated with systemic conditions such as psoriatic arthritis metabolic and cardiovascular diseases and psychiatric disorders.
In Unani medicine psoriasis is known as Da us Sadaf or Taqashshur al Jild and is attributed to imbalances such as Ufoonate Rutoobat Hiddate Khoon and excessive heat in Safra and Sauda. The Unani treatment approach includes Tasfiyah e Dam blood purification Jali cleansing Tehleel e Auram anti inflammatory and Tarteeb moisturization therapies.
The present study aims to evaluate the safety and efficacy of two Unani formulations Nuqooe Musaffi oral and Marhame Surkh topical. After obtaining informed consent patients will be randomized into two groups. Group one Test group will receive Nuqooe Musaffi orally every morning and Marhame Surkh topically twice daily. Group two Control group will receive Betamethasone valerate 0.1 percent cream applied twice daily. Blood samples will be taken at baseline and at the final visit for pathological and biochemical analysis to assess clinical outcomes and treatment effectiveness. |