A comparative clinical study to evaluate the efficacy of bakuchi compound and khadira kwathawith and without virechana in the management of shwitra w.s.r. to vitiligo.
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Primary outcome: Assessment of changes in specific signs and symptoms of shwitra
研究概览
简要总结
The disease Shwitrais posing bigchallenge to the medical world. Although the disease is known to all sincelong-back, but no satisfactory treatment protocol is available for managementin contemporary medical sciences. All age group people are affected from thisdisease. Ayurveda management seems to be more satisfactory because oftheir long lasting effects and multiple systematic regenerative actionswithout any harm. Previously no research work has been done with this trialdrugs “Bakuchi compound and khadira kwatha†withand without virechana. So, the present study has been plannedto provide an effective, cost effective treatment for shwitra (vitiligo) byusing Ayurveda principle.
STUDYDESIGN:
**Study type-**Interventional
Purpose –Treatment
Masking –Open label
Timing- Prospective
Administrationof Drugs:- The 60clinically diagnosed patient of Shwitra will be equally divided into twogroups.
Group A– 15Patients will be administered trial drugs- “Bakuchi Compound†5gmtwice a day and“Khadira Kwathaâ€40 ml twice daily orally for 60 days.
Group B**-**Patients of this group will beperformed Virechanakarmabefore the trial drugs-“Bakuchi Compoundâ€5gm twice a day and “Khadira Kwathaâ€40 ml twice daily orally for 60days.
Patientwill be assessed clinically on 1stday, 30th dayand 60th day i.e. at the end of the trial
Resultof the trial:
Resultsin patients of Group A: In Group A, patients treated with “Bakuchi Compound†and “Khadira Kwatha†showed percentagewise improvement in subjective parameters such as Rukshata, Daha and Kandu but statistically shown non-significantresults (p>0.05). In hair fall (Romaparidhwamsi), there was no relief found clinically orstatistically. It showed non-significant result (p value >0.05).In case of objective parameters, percentage wise improvement was found in thesize of the patches where the mean score before treatment was 37.15which decreased to 33.38, giving adecrement of 10.12 % which was statistically highly- significant (p<0.01). Colourof the skin showed statistically highly significantresult where the mean score before treatment was 1.38 which was increased to2.15 (as the colour improvement score was in ascending order) after treatment,with a relief of 34.6% which was statistically highly significant with p value 0.002 (p<0.01). Incase of Lab. Investigations, there were no statistically significant changesfound in any of the variables.
Results inpatients of Group B: InGroup B, patients treated with VirechanaKarma prior toadministration ofthe same trial drugs “Bakuchi Compoundâ€and “KhadiraKwathaâ€. It showed percentage wise improvement in subjectiveparameters such as Rukshata, Daha and Kandu but statistically shown non-significant results (p>0.05). In hair fall (Romaparidhwamsi), there was no relief found clinically orstatistically. In case of objective parameters, percentage wise improvement was found in the size of the patches whichwas statistically highly- significant.The mean score before treatment was 42.26 which decreased to 28.00 aftertreatment, giving relief of 33.76% which was statistically highly-significant (p<0.001). Incase of the colour of the skin, the mean score before treatment was 1.33 whichwas increased to 2.86 (as the colour improvement score was in ascending order)after treatment, with a relief of53.3% which was statistically highly-significantwith p value is <0.001.Laboratory investigations - only SGOT level had shown statistically highly- significant result (p<0.01). Nosignificant changes were found in any other haematological or bio-chemicalvariables.
**Intergroupcomparison:**On intergroup comparison there was no statistically significant difference inall subjective parameters.In objectiveparameters, the size of the patches showed statistically highly-significant (p<0.01) result. The p value 0.041 (p<0.05) wasfound on intergroup comparison in colour change, which was statisticallysignificant, that means there was difference in efficacy of both the treatmentson Shwitra.
Conclusion:
The result ofboth therapies was statistically highly significant in reducing the size ofpatch and change of colour in both the groups. The patient of Group-B where Virechana was performed showed betterresult in both subjective and objective parameters than Group-A. It signifies theimportance of Shodhana Chikitsa in Shwitra. So, according to classical text, repeateduse of Shodhana therapy may bring significant result in thetreatment of this disease. Therapy was well tolerated by all the patients.There were no adverse effects or complications found during the trial period. Thestudy has revealed that there was no adverse effect on renal and liverfunction test. Thus, finally it can be concluded that the drug “Bakuchi Compound†and “Khadira Kwatha†issafe, cost effective & free from any side effects in the management of Shwitra.
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研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 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
- •1.Patients in the age group of 18 to 60 years of either sex.
- •2.Patient diagnosed as shwitra (vitiligo) on the basis of clinical features mentioned in Ayurveda texts.
- •3.Patients fit for virechana.
- •4.Patient with history of shwitra less than or equal to five years.
- •5.Patient willing to participate in the clinical trial.
排除标准
- •1.Patient with age group of less than 18 years and more than 60 years.
- •2.White anesthetic spots, which are characteristic of leprosy.
- •3.Patches in genital areawill be excluded from the study.
- •4.Vitiligo patches complicated with eczema.
- •5.Patients with evidence of malignancy, diabetes mellitus with complication, albinism.
- •6.Pregnant women and lactating mother.
- •7.Patient participated in any clinical trial within last six months.
结局指标
主要结局
Primary outcome: Assessment of changes in specific signs and symptoms of shwitra
时间窗: 60 days
Secondary outcome: Any adverse effect in the values of haematological test and in clinical signs and symptoms.
时间窗: 60 days
次要结局
- Any adverse effect in the values of haematological test and in clinical signs and symptoms.(60 days)