AN OPEN PILOT STUDY ON THADIPPU PERUNOI (PSORIASIS) WITH THE TRIAL DRUG “PANCHAMUGA CHENDHURAM†(INTERNAL) AND “KUNDAVAATHI THAILAM†(EXTERNAL).
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Primary outcome is mainly assessed by reduction in clinical symptoms like itching and scaling.
研究概览
简要总结
Psoriasis is a lifelong, chronic, immune mediated, inflammatory skin condition affecting 2% of general population. It is common in both men and women. The typical skin lesions are well defined, red, indurated plaques with silvery scales. However The effective treatment of this disease is limited.
The Siddha herbo-mineral formulation “Panchamuga chendhuram†(PMC) and Siddha polyherbal formulation“Kundavaathi****thailam†mentioned in classical siddha literatures indicated for all skin diseases are selected for this study. It is an open labedcomparitive study on psoriasis patients with the trial drug “PMC†(internal) and “Kundavaathi thailam†(external). PMC is given for 20 patients,50mg dosage, twice a day for 48 days, and for another 20 patients PMC is given along with Kundavaathi thailam for external use. PMC Contains Purified Hydragyrum, Purified Sulphur, Purified Mercuric II sulphide, Purified Mercuric chloride, Purified Arsenic trisulfide, Piper betel leaf juce. Kundavaathi thailam contains azima tetracantha, alangium salvifolium, smilax china, aegle mamelos,withania somnifera, alpinia galangal,picrorhiza scropulariflora, helicteres isora, santalum album, piper nigrum, scindapsus officinalis, styrax benzoin, Gingilley oil, Cow’s milk
The Physicochemical analysis of PMCwas done in SAIF, IIT MADRAS. SEM analysis reveals the presences of particle size ranges
from ~50nm- ~500nm. SEM with EDAX indicated the considerable amount of sulphur, mercury, arsenic and oxygen. In FTIR the functional
groups such as carbonyl group, hydroxyl group, nitrogen compound are present. These functional groups have specific effect on skin. In
ICPOES Presence of heavy metals such as Hg, As, Pd, Cd, Fe, Cu are in considerable limits.
Hence , the present study have to be carried out to evaluate the efficacy and saftey of the drugs “PMCâ€, “Kundavaathi thailamâ€.
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
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Patches with Scaling.
- •Auspitz Sign + Koebner’s Phenomenon + Willing to give specimen of blood for the investigation whenever required.
- •Willing to give photographs before and after treatment (Ensuring confidentiality).
排除标准
- •Hypertension,Diabetes mellitus,Narcotic addicts,Psoriatic arthropathica,Cardiac disease Leprosy,Peptic ulcer,SLE,progressive systemic sclerosis,Evidences of secondary infection in the lesions,Pregnancy, lactation,HIV.
结局指标
主要结局
Primary outcome is mainly assessed by reduction in clinical symptoms like itching and scaling.
时间窗: 12 months
PASI Score (Psoriasis area severity index)
时间窗: 12 months
次要结局
- •Secondary outcome is assessed by comparing the safety parameters before and after treatment.(12 months)