A COMPARATIVE STUDY OF CODED UNANI FORMULATION UNIM 001 UNIM 003 AND NB UVB THERAPY IN CASES OF BARAS VITILIGO FOLLOWUP STUDY
试验速览
- 阶段
- 2/3 期
- 状态
- 尚未招募
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- State of immunity before and after treatment through cytokine analysis IFN gamma IL 10 IL 6, IL1beta and TNF alpha
研究概览
简要总结
The test drugs are coded unani formulations are effective in our previous studies. The time of treatment is approximately 8 months to 1 year. In our pilot studies we have observed when these coded formulations are given along with NB UVB therapy in a closed chamber the period of repigmentation of the affected site are reduced to approx to one third.
In this study subject will be randomly divided into three groups 20 patients in each and they will receives Test drug UNIM 001 UNIM 003 and its identical placebo along with the NB UVB therapy.
We are also looking for the intricate relationship between oxidative stress and autoimmune processes in effective treatment for vitiligo.
We are also looking for levels of vitamin D at the baseline to understand the health status of the enrolled patients.
The outcome of the results will be based on observation Digital photography reduction in VASI VIDA Repigmentation score through mexameter as RMI Relative Melanin Index. Along with the improvement in the stress markers inflammatory markers and QoL of the enrolled patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 12.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients with clinically diagnosed segmental and non-dermatomal vitiligo.
- •Subjects with 12 -60 years of age.
- •Either gender.
- •Willingness to give written informed consent form.
排除标准
- •Subjects with active vitiligo treatment with other drugs/systems Non-cooperative subjects.
- •H/o of drug or alcohol abuse, chronic smokers not willing to abstain from smoking during the study period.
- •Any clinically significant abnormality identified on physical examination or laboratory tests.
- •Subjects having any systemic disease and other skin diseases.
- •Subjects with known allergies.
- •Impaired Cardiac, Hepatic and Renal function.
- •History of malignancy.
- •Concomitant use of any other antioxidants.
- •History of hypersensitivity to any of the investigational drugs/herbal medicine.
- •Receiving any other investigational product within 4 weeks.
- •Any medical condition, where physician feels participation in the study could be detrimental to subjects well being.
- •Uncontrolled infection.
- •Pregnant and lactating women.
结局指标
主要结局
State of immunity before and after treatment through cytokine analysis IFN gamma IL 10 IL 6, IL1beta and TNF alpha
时间窗: To study and ensure the cosmetically acceptable repigmentation with 40 percent to 50 percent decrease in VASI Score To evaluate the overall safety toxicity acceptability of unani coded drugs. To evaluate the decrease in the treatment duration with the NB UVB Therapy. To study the state of immunity and oxidative stress in pre and post treatment cases along with the vitamin D at baseline.
State of oxidative stress before and after treatment through Lipid peroxidation superoxide dismutase nitric oxide catalase and reactive oxygen species.
时间窗: To study and ensure the cosmetically acceptable repigmentation with 40 percent to 50 percent decrease in VASI Score To evaluate the overall safety toxicity acceptability of unani coded drugs. To evaluate the decrease in the treatment duration with the NB UVB Therapy. To study the state of immunity and oxidative stress in pre and post treatment cases along with the vitamin D at baseline.
State of Vitamin D in the baseline.
时间窗: To study and ensure the cosmetically acceptable repigmentation with 40 percent to 50 percent decrease in VASI Score To evaluate the overall safety toxicity acceptability of unani coded drugs. To evaluate the decrease in the treatment duration with the NB UVB Therapy. To study the state of immunity and oxidative stress in pre and post treatment cases along with the vitamin D at baseline.
次要结局
- To evaluate the state of immunity before and after treatment in cases of vitiligo Baras along with the NB UVB therapy through the biochemical markers eg Th1 through IFN gamma Th2 through IL 10 and Th 17 through IL-6 IL 1 beta and TNF alpha and inflammatory markers as IFN gamma and TNF alpha.(To evaluate the oxidative stress Lipid peroxidation superoxide dismutase nitric oxide catalase and reactive oxygen species)
研究者
Dr Misbahuddin Azhar
Regional Research Institute of Unani Medicine