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临床试验/CTRI/2018/05/014097
CTRI/2018/05/014097招募中1 期

COMPARATIVE STUDY OF VIRECHANA KARMA AND JYOTISMATI TAIL (ABHAYANG) IN THE MANAGEMENT OF SHVITRA WSR OF VITILIGO

Uttarakhand Ayurved University1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2018年1月15日最近更新:

试验速览

阶段
1 期
状态
招募中
发起方
入组人数
40
试验地点
1
主要终点
•Marked improvement :76% to 100%

研究概览

简要总结

AIMS& OBJECTIVES

1.     To evaluate the efficacy of Virechana karma  in the management of Shvitra.

2.     To evaluate the efficacy of by Jyotismati Tail Abhayag (Ekang/Sarvang ) inthe management of  Shvittra.

3.     To compare the effect of Virechana karma and Jyotismati Tail Abhayag (Ekang/Sarvang in the management of Shvitra.

MATERIAL AND METHODS

Procedure of Virechana Karma

**Purva Karma –**For Deepan, Pachana Karma, Trikatu churna willbe given in a dose of  3 to 6 gms BD asper the koshtha of patients.

**Pradhana karma -**After administration of snehana and on emptystomach after the time of Kapha has been pass Nishothadi Kwatha will be given to thepatient as per kostha of patient.

Paschata Karma – Patient should adviced for SansarjanaKarma as per type of Shuddi obtaine.

Purva Karma – Ask to the patient to wash the affected ariawith lukewarm water prior to application of Jyotismati Tail Abhayang.

Pradhana karma -    Freshly prepared and Jyotismati Tail Abhayag (Ekang/Sarvang ) applie the over affected aria.

Paschata Karma – Patients suffer from mild to moderateburning sensation afterapplication of abhayang. Blister got develop within 2 to3 days after application of oil .Till they get disappear as new skin grows .

PLAN OF STUDY:

ClinicalStudy: For the clinical study, patients attendingOPD and IPD of the Panchkarma Department of Rishikul Campus, Haridwar.

Total No. of Patients      : 40

Type of study                : openstudy

Level of study               : O.P.D.& I.P.D. level

Period of study :         60 days

FOLLOW UP: Thefollow up will be of one month after completion of treatment to observe the effectof treatment or any adverse effects etc.

B) INCLUSIONCRITERIA**-**

•      Vitiligowith classical signs and symptoms.

•      Agegroup 15 to 70 years.

C) EXCLUSIONCRITERIA-

•      Pregnantwomen and lactating women.

•      Vitiligolinked with other disease that is Hypertension, Diabetes, Tuberculosis,Rheumatoid Arthritis, and Anemia.

•      Patchesover genital areas.

•      Knowncases of leprosy.

•      Rapidlyspreading Vitiligo patches and associated with blisters and rubor duringtreatment.

•      Vitiligopatches complicated by eczema and burns.

•      Extensiveand complete dipigmented Vitiligo.

•      Congenitalpigmentation disorders.

For present study minimum 40 patients will beselected on the basis of inclusion & exclusion criteria

D) SAMPLESIZE- 40 patients will be taken for the study

Grouping: Ineach group 20 patients will be taken for trial.

Group A –Patients in this group will be administered with 2 Sittings of Virechana  karma procedure.FirstDeepan-Paachan then Snehapaan followed by administrationof Virecnana dravy*.*Then,Samsarjana karma will be followed as pertype of shudhhi.

GROUPB: -20 patients of Shivitra will be treated with externally .

Classical virechanakarma includes Deepana ,Pachana,Snehpana, Abhyanga and Swedana administrationSanshodana kalpa and Samsarjana karma.

Demographic   data  was  collected  from  the registered patients  along  with base line  assessment  as per  the  proforma. Periodic  assessment  of  the  signs  and symptoms  was  done  at interval of  15-15 days .A follow-up assessmentwill be done after  2 month to check  the recurrence or any associated complainafter withdrawing the therapy .

CRITERIA FOR WITHDRAWAL

§ Personal Matters.

§ Aggravation of complaints.

§ Inter-current illness.

§  Any otherdifficulties.

§ Leave against medical advice (LAMA).

OBSERVATION &ASSESSMENT:

Observationwill be carried out at interval of 15 days for 60 days.

Observationof patient will be carried out before, during and after the treatment.

Patientswill be evaluated for severity of illness during and after the interventionbased on parameters and investigations.

·        Any addition or exclusionmay be included as necessity of the study.

Assessmentwill be done statistically.

ResearchProforma**:****:**A detailed  research Proforma will beprepared incorporating all the points from Ayurvedic as well as modernaspect to study the patients as well as disease.

CRITERIA FORASSESSMENT

}  Theimprovement in patients will be asses on the basis of relief in sign andsymptoms of the disease. All the signs symptoms were givenscoring depending upon their severity to assess the effect except VASI Whichwas directly calculated by using the formula (VASI= HAND UNITS]×[RESIDUAL DEPIGMENTION])after each visit of the patient for better assessment of the trial methodologyused.Color -

}  Normalskin color – 0

}  Redcolor              – 1

}  RedPale              –  2

}  Palewhite            –  3

Margin

}  Normalskin color attributed.                                        –  0

}  Hyper-pigmentedthick broad with graduated margin.      –1

}  Hyper-pigmentedbroad with graduated margin.              â€“ 2

}  Hyper-pigmentedwell defined margin.                            â€“ 3

}  Hyper-pigmentedthin edge margin.                                 – 4

}  Welldefined margin.                                                       â€“5

     Signsand symptoms

Color-;

Normalskin color – 0

Redcolor              â€“ 1

RedPale              â€“  2

Palewhite            –  3

Margin;

Normalskin color attributed.                                        â€“  0

Hyper-pigmentedthick broad with graduated margin.  â€“ 1

Hyper-pigmentedbroad with graduated margin.          â€“ 2

Hyper-pigmentedwell defined margin.                         â€“ 3

Hyper-pigmentedthin edge margin.                             â€“ 4

Welldefined margin.                                                      â€“5

INVESTIGATIONS:

                                      o   Hb%Waist

o   circumference(ininches)

o   T.L.C

o   D.L.C

o   Randomblood sugar.

o   Waistcircumference(in inches)

o   Totalcholesterol/HDL

o   HDL/LDL.

o   Erythrocytesedimentation rate (ESR).

Theseinvestigations will be carried out before and after completion of therapy.

  STATISTICAL ANALYSIS:.

To obtain the efficacy ofthe therapy on Objective parameters, properstatistical analysis will be cerried out of available data.

1.     Within the groupparametric by – t- paired.

2.     Within the group  non-parametric by Wilcoxon test.

3.     Inter groupparametric by Chi- squared.

4.     Inter groupnon-parametric by Mann- Whitney U test.

CONCLUSION:

Theresult will be analyzed statistically and discussed. Conclusion will be made onthe basis of the observation which is done on subjective parameters.

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
15.00 Year(s) 至 70.00 Year(s)(—)
性别
All

入选标准

  • Classical Sign of Vitiligo.

排除标准

  • Complicated Condition.

结局指标

主要结局

•Marked improvement :76% to 100%

时间窗: •Marked improvement :76% to 100% | •Moderate improvement:51% to 75 % | •Mild improvement :26 % to 50 % | •No improvement : 0% to 25 %

•Moderate improvement:51% to 75 %

时间窗: •Marked improvement :76% to 100% | •Moderate improvement:51% to 75 % | •Mild improvement :26 % to 50 % | •No improvement : 0% to 25 %

•Mild improvement :26 % to 50 %

时间窗: •Marked improvement :76% to 100% | •Moderate improvement:51% to 75 % | •Mild improvement :26 % to 50 % | •No improvement : 0% to 25 %

•No improvement : 0% to 25 %

时间窗: •Marked improvement :76% to 100% | •Moderate improvement:51% to 75 % | •Mild improvement :26 % to 50 % | •No improvement : 0% to 25 %

次要结局

  • •Marked improvement :76% to 100%(•Moderate improvement:51% to 75 %)

研究者

发起方
Uttarakhand Ayurved University
申办方类型
Government medical college

研究点 (1)

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