An open clinical study to evaluate the clinical efficacy of siddha sasthric formulation Ilaguseena chooranam for the treatment of venpadai
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- The Therapeutic Efficacy of Trial drug Ilaguseena Chooranam on Venpadai
研究概览
简要总结
STUDY ENROLMENT
In this study, patients reporting at the OPD with the clinical symptoms of patchy loss of skin colour. Premature whitening or graying of the hair on scalp, eye lashes, eye brows or beard. loss of colour in the tissues that lines inside the mouth,nose. *Patient will be examined clinically for enrolling in the study based on inclusion and exclusion criteria.*The patients who are to be enrolled patients would be informed (Form IV) about the study, trial drug, possible outcomes and the objectives of the study in the language and terms understandable to them and to their informants. After ascertaining the parent’s willingness, informed consent would be obtained in writing from them in the consent form (Form IV-A). All these patients will be given unique registration card in which patient’s registration number of the study address, phone number and Doctor’s phone number etc. will be given, So as to report easily if any complications arise. Complete clinical history, complications and duration, examination findings – all would be recorded in the prescribed proforma in the history and clinical assessment forms separately. Screening form- I will be filled up; Form I-A, Form II and Form III will be used for recording the patient’s history, clinical examination of symptoms, signs and laboratory investigations respectively. Patients would be advised to take the trial drug and appropriate dietary advice (Form IV-D) would be given according to the patient’s perfect understanding.
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Open Label
入排标准
- 年龄范围
- 2.00 Year(s) 至 12.00 Year(s)(—)
- 性别
- All
入选标准
- •Hypo pigmented patches with hyper pigmented border without any structural changes in any part of the body.
- •vitiligo present any part of the body.Patients who are willing to stay in IPD Ward for 27 days or willing to attend OPD.
- •Children who are willing to undergo investigation and give blood and urine samples for laboratory investigation.
- •Patient’s informant / Parent willing to sign the informed consent stating that he/she will consciously stick to the treatment during 27 days but can opt out of the trial of his / her own conscious discretion.
排除标准
- •Albinism Dermatological aspect of leprosy Tinea versicolor Burn scars Dermatological aspect of addisons diseases Post inflammatory hypopigmentation Pityriasis alba Alopecia aerate chemical leucoderma white patches on mucous membrane.
结局指标
主要结局
The Therapeutic Efficacy of Trial drug Ilaguseena Chooranam on Venpadai
时间窗: 27 days
次要结局
- Evaluation of Siddha Diagnostic Parameters(27 days)
