Impact of Shodhana on Phyto-pharmacological properties of different source plants of Karavira root bark and clinical efficacy of Rakta karavira taila on Vicharchika.
试验速览
- 阶段
- 1/2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Relief in Itching,Burning sensation,Roughness,Pain etc.
研究概览
简要总结
An open labelled pilot clinical study was carried out toassess the role of Rakta KaravÄ«ra Taila on patients of VicarcikÄ after gettingapproval of IEC (Ref no: PGT/7/-A/ethics/2015-16/2796;Dated-25/11/2016). The study was registered in CTRI (CTRI/2017/06/008823;Dated-13/06/17). Clinically diagnosed 30cases of VicarcikÄ among the patients visiting the OPD of Dravyaguna departmentwere selected. Test drug was supplied to all the patients weekly for topicalapplication (as per surface area of lesion) for a duration of 4 week (28 days). Weekly assessment was done by self-assessmentquestionnaire and EASI (eczema area and severity index) score parameters.
Among 30 patients, 2 discontinued due to personal reasonsat very begining. In the registered 28 cases who completed the treatment.Statistical analysis was done by applying Unpaired’t’-test for assessing thedifference of pre and post EASI score.
Afterweekly assessment it was found that there was progressive improvement observedin all the considering symptoms of VicarcikÄ like Kaṇdu, PidikÄ, VaivarnyatÄ,DÄha, VedandÄ and Ruká¹£atÄ up to 3rd week of study period. After thatrelief was steady in case of DÄha and VedanÄ, slow improvement in Kaṇdu,VaivurnyatÄ and Ruká¹£atÄ. Decrease in relief in case of PidikÄ was observed on 4thweek.
Ovar all effect of Therapy: There was mild tomoderate improvement in the score after treatment as per Äyurvedic parameter aswell as EASI parameters. One patient didn’t show any improvement on the basisof EASI parameters. Overall effect of Therapy on chief complaints like Kaṇdu(Itching) 60.49% relief; Piá¸ikÄ (Pappilae) got 33.33% relief; VaivarṇyatÄ(Discolouration) got 43.90% relief; DÄha (Burning sensation) got 50% relief;VedanÄ (Pain) got 80% relief and Ruká¹£atÄ (Dryness) got 57.32% relief. Effect ofTherapy on EASI parameters like Redness got 42.86% relief; Thickness got 55.56%relief; Scratching got 45.06% relief and Lichenification got 41.67% relief. Noadverse reactions were reported during trail.
1. RaktaKaravÄ«ra Taila, an anubhuta yoga is a fast acting drug against all the assessedsymptoms of VicarcikÄ like Kaṇá¸u, PidikÄ, VaivarnyatÄ, DÄha, VedandÄ and Ruká¹£atÄ.However, rate of improvement was slow down between 3rd and 4thweek, but was still improving instead except in case of PidikÄ.
2. RaktaKaravÄ«ra Taila has a mild to moderate improvement in reducing the symptoms ofVicarcikÄ within 28 days of administration.
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 70.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Classical signs and symptoms of Vicharchika lika Kandu,Pidika,Vaivarna,Daha,Rukhshata,vedana etc.
- •2.Uncomplicated case of Vicharchika.
- •3.Acute case of < 1 year history.
排除标准
- •1.Suffering with systemic diseases like Diabetes,Hypertension,Malignancy,Tuberculosis,Renal diseases,Liver diseases etc.
- •2.Chronic case of > 1year history.
- •3.Lession of larger surface area.
结局指标
主要结局
Relief in Itching,Burning sensation,Roughness,Pain etc.
时间窗: 28 days
symptoms of Vicharchika.
时间窗: 28 days
次要结局
- Kandu(Itching),Pidika(Furuncle),Vaivarnata(Discoloration),Daha(Burning sensation),Rukshata(Roughness),Vedana(Pain)etc.(up to 28 days)