A clinical trial to compare the effects of coded Unani research drugs UNIM 001+UNIM003 with Psoralen in the treatment of vitiligo

• Register: CTRI
• Last refreshed on: 24 November 2021
• Main ID: CTRI/2013/12/004215
• Date of registration: 13-12-2013
• Prospective Registration: No
• Primary sponsor: Central Council for Research in Unani Medicine CCRUM New Delhi
• Public title: A clinical trial to compare the effects of coded Unani research drugs UNIM 001+UNIM003 with Psoralen in the treatment of vitiligo
• Scientific title: A multicentric single blind, randomized, parallel group, comparative study to compare the efficacy and safety of Coded Unani formulations UNIM 001+UNIM003 with Psoralen in the treatment of Bars (vitiligo )
• Date of first enrolment: 29-03-2013
• Target sample size: 532
• Recruitment status: Open to Recruitment
• URL: http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=6281
• Study type: Interventional
• Study design: Randomized, Parallel Group, Active Controlled Trial; Method of generating randomization sequence:Stratified block randomization Method of allocation concealment:Sequentially numbered, sealed, opaque envelopes Blinding and masking:Participant Blinded
• Phase: Phase 2

Countries of recruitment

India

Contacts

• Name: Dr Abdul Hannan
• Affiliation: Central Council for Research in Unani Medicine (CCRUM),

• Name: Dr Abdul Hannan
• Affiliation: Central Council for Research in Unani Medicine (CCRUM),

Key inclusion & exclusion criteria

Inclusion criteria: 1. Patients with clinically diagnosed dermatomal and non-dermatomal vitiligo

2. Subjects with 8 -50 years of age.

3. Either gender

4. With any duration of disease, site, extension and distribution of lesions

5. Willingness to give written informed consent form.


Exclusion criteria: 1. Subjects with active vitiligo treatment with other drugs/systems

2. Non-cooperative subjects

3. H/o of drug or alcohol abuse, chronic smokers not willing to abstain from smoking during the study period

4. Any clinically significant abnormality identified on physical examination or laboratory tests

5. Subjects having any systemic disease and other skin diseases.

6. Subjects with known allergies

7. Impaired Cardiac, Hepatic and Renal function

8. History of malignancy

9. Concomitant use of any other antioxidants

10. History of hypersensitivity to any of the investigational drugs/herbal medicine.

11. Receiving any other investigational product within 4 weeks

12. Any medical condition, where physician feels participation in the study could be detrimental to subjects well being.

13. Uncontrolled infection

14. Pregnant and lactating women.



Age minimum:
Age maximum:
Gender:

Health Condition(s) or Problem(s) studied

Health Condition 1: null- VITILIGO Health Condition 2: L80- Vitiligo

Intervention(s)

Intervention1: UNIM-001 AND UNIM-003: UNIM-001 given orally according to per kg body body weight as mentioned in the protocol and UNIM003 given for topical application
Duration of treatment is 8 months followed by 3 months post-treatment follow-up.
Age Dose(mg)ofUNIM001&frequen
12-18 1600mg 1 b.i.d.
18-30 2400mg 1 t.i.d
30-50 3200mg 2 b.i.d

Control Intervention1: psoralen: Age Dose (mg) of psoralen
12-18 20 mg
18-30 30 mg
30- 50 40 mg

Age Frequency
12-18 2tablets Single dose
18-30 3tablets Single dose
30-50 4tablets Single dose
Duration of treatment is 8 months followed by 3 months post-treatment follow-up.

Primary Outcome(s)

1. To study and ensure the cosmetically acceptable re- pigmentation with 40% to 50% increase in VASI Score

2 To determine the time of initial re-pigmentation and subsequently the rate of re-pigmentation.

Timepoint: 8 MONTHS

Secondary Outcome(s)

1 To evaluate the overall safety, toxicity, acceptability of Unani drugs.

2 To study the Post- treatment retention of re-pigmentation at least for 3 months.

3. To evaluate the % of study participants responding to the Unani treatment and psoralen.

Timepoint: 8 MONTHS

Secondary ID(s)

NIL

Source(s) of Monetary Support

Infrastructural support : 1. Central Research Institute of Unani Medicine (CRIUM), Hyderabad 2. Regional Research Institute of Unani Medicine(RRIUM), Aligarh 3. Regional Research Institute of Unani Medicine (RRIUM), Srinagar 4. Regional Research Institute of Unani Medicine (RRIUM), New Delhi Monetary Support : Central Council for Research in Unani Medicine (CCRUM), New Delhi

Ethics review

Status: Approved
Approval date: 02/02/2013
Contact:

CRIUM HYDERABAD INSTITUTIONAL ETHICS COMMITTE, HYDERABAD, DR M A WAHEED, PRINCIPAL INVESTIGATOR

Status: Approved
Approval date: 06/02/2013
Contact:

RRIUM NEW DELHI INSTITUTIONAL ETHICS COMMITTEE, NEW DELHI, DR NAHEED KHATOON, PRINCIPAL INVESTIGATOR

Status: Approved
Approval date: 28/03/2013
Contact:

RRIUM ALIGARH INSTITUTIONAL ETHICS COMMITTEE, ALIGARH, DR PARVEZ KHAN, PRINCIPAL INVESTIGATOR

Status: Approved
Approval date: 19/11/2013
Contact:

RRIUM SRINAGAR INSTITUTIONAL ETHICS COMMITTEE, SRINAGAR, DR ARJUMAND SHAH, PRINCIPAL INVESTIGATOR