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 )
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 532
- 试验地点
- 2
- 主要终点
- 1.To study and ensure the cosmetically acceptable re- pigmentation with 40% to 50% increase in VASI Score
研究概览
简要总结
This study is designed as 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). Self-reporting Vitiligo patients at Central Research Institute of Unani Medicine, Hyderabad/ and other allotted centres under CCRUM, will be assessed which will form the source of subjects for the study. Approximately in and around 532 clinically diagnosed Vitiligo patients with various ages, chronicities and of either gender will be enrolled in the study subject to fulfillment of inclusion criteria.
After screening, participants will be divided into 2 arms. First arm will receive the study drug– UNIM001+UNIM003 while the second arm will receive psoralen as treatment. The total duration of treatment will be 8 weeks All the parameters will be recorded at baseline, clinical follow up will be done once in a month for their evaluation as rate & % of re-pigmentation including the safety and efficacy parameters like LFT, RFT, ECG-QT interval. Follow up evaluation will be at least for 3 months to assess the retention of re-pigmentation. Response will be evaluated as follicular and peri-lesional re-pigmentation over the de-pigmented areas. Rate of % of re-pigmentation will be assessed. QOL index will be recorded initially and at the end of the study. Post-treatment follow-up will be done for 3 months in order to see the rate of re-pigmentation retained by the participants
Age related dosing of psoralen 8-12 years:10 mg; 13-18 years: 15 mg; 19 years & above20 mg.
| Age (in yrs) |
Weight (Kgs)
Dose(mg)** of psoralen
Frequency
|12-18
30-50 ±5%
20
(2 tablets)Single dose
|>18-30
50-60±5%
30
(3 tablets)Single dose
|>30-50
60-70 ±5%
40
(4 tablets)Single dose
Ingredients of UNIM-001 -
-
Babchi,
-
Zanjabeel,
Ingredients of UNIM-003 ,
-
Babchi ,
-
Gulnar
研究设计
- 研究类型
- Interventional
- 分配方式
- Stratified block randomization
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 8.00 Year(s) 至 50.00 Year(s)（—）
- 性别
- All
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
1.To study and ensure the cosmetically acceptable re- pigmentation with 40% to 50% increase in VASI Score
时间窗: 8 MONTHS
2 To determine the time of initial re-pigmentation and subsequently the rate of re-pigmentation.
时间窗: 8 MONTHS
次要结局
- 1To evaluate the overall safety, toxicity, acceptability of Unani drugs.(2To study the Post- treatment retention of re-pigmentation at least for 3 months.)