To see the efficacy of bakuchi compound and khadira kwatha with and without virechana karma in the the management of shwitra(Vitiligo).

Phase 2

Completed

• Conditions: Vitiligo,

• Registration Number: CTRI/2019/05/019012
• Lead Sponsor: National Institute of Ayurveda

Brief Summary

The disease *Shwitra*is 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 kwathaâ€* 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** â€“Treatment

**Masking** â€“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 Kwatha*â€40 ml twice daily orally for 60 days.

**Group B****-**Patients of this group will beperformed *Virechanakarma*before the trial drugs-“*Bakuchi* Compoundâ€5gm twice a day and “*Khadira Kwatha*â€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 Kwathaâ€* 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-significant**with 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*â€* and “*Khadira Kwathaâ€* issafe, cost effective & free from any side effects in the management of *Shwitra.*

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Detailed Description

Not available

Study Timeline

• Study Start: 2019-10-31
• Study Completion: 2020-04-20
• Last Update Posted: 2020-07-07

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Primary outcome: Assessment of changes in specific signs and symptoms of shwitra	60 days
Secondary outcome: Any adverse effect in the values of haematological test and in clinical signs and symptoms.	60 days

Secondary Outcome Measures

Name	Time	Method
Any adverse effect in the values of haematological test and in clinical signs and symptoms.	60 days

Trial Locations

Locations (1)

OPD and IPD of PG Department of Kayachikitsa, National Institute of Ayurveda; 🇮🇳 Jaipur, RAJASTHAN, India

OPD and IPD of PG Department of Kayachikitsa, National Institute of Ayurveda

🇮🇳Jaipur, RAJASTHAN, India

Dr Ashis Das

Principal investigator

9862922712

dr.ashisdas2010@gmail.com