| CTRI Number |
CTRI/2019/05/019012 [Registered on: 09/05/2019] Trial Registered Prospectively |
| Last Modified On: |
07/07/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To see the efficacy of bakuchi compound and khadira kwatha with and without virechana karma in the the management of shwitra(Vitiligo). |
|
Scientific Title of Study
|
A comparative clinical study to evaluate the efficacy of bakuchi compound and khadira kwatha
with and without virechana in the management of shwitra w.s.r. to vitiligo.
|
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr HML Meena |
| Designation |
Associate professor |
| Affiliation |
National Institute of Ayurveda |
| Address |
PG Department of Kayachikitsa National Institute of Ayurveda, Madhav Vilas Palace,Amer road, Jorawar Singh Gate,Jaipur,Rajasthan
Jaipur
RAJASTHAN
302002
India |
| Phone |
9461297017 |
| Fax |
|
| Email |
hari_mohan68@yahoo.co.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr HML Meena |
| Designation |
Associate professor |
| Affiliation |
National Institute of Ayurveda |
| Address |
PG Department of Kayachikitsa National Institute of Ayurveda, Madhav Vilas Palace,Amer road, Jorawar Singh Gate,Jaipur,Rajasthan
Jaipur
RAJASTHAN
302002
India |
| Phone |
9461297017 |
| Fax |
|
| Email |
hari_mohan68@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr HML Meena |
| Designation |
Associate professor |
| Affiliation |
National Institute of Ayurveda |
| Address |
PG Department of Kayachikitsa National Institute of Ayurveda, Madhav Vilas Palace,Amer road, Jorawar Singh Gate,Jaipur,Rajasthan
Jaipur
RAJASTHAN
302002
India |
| Phone |
9461297017 |
| Fax |
|
| Email |
hari_mohan68@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
| National Institute of Ayurveda, Jaipur, Rajasthan, 302002 |
|
|
Primary Sponsor
|
| Name |
National Institute of Ayurveda |
| Address |
Madhav Vilas Palace,Amer road, Jorawarsingh gate,Jaipur, Rajasthan. |
| Type of Sponsor |
Research institution and hospital |
|
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Details of Secondary Sponsor
|
|
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Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Ashis Das |
OPD and IPD of PG Department of Kayachikitsa, National Institute of Ayurveda |
Madhav Vilas Palace, Jorawar Singh Gate, Amer Road, Jaipur
Jaipur
RAJASTHAN |
9862922712
dr.ashisdas2010@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee, National Institute of Ayurveda, Jaipur, Rajasthan |
Approved |
|
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Regulatory Clearance Status from DCGI
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: L80||Vitiligo, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Bakuchi Compound, KhadiraKwatha and Virechana Karma
|
Group A– 15 Patients will be administered trial drugs- Bakuchi Compound 5gm twice a day and KhadiraKwatha40 ml twice daily orally for 60 days.
Group B–Patients of this group will be performed virechana before the trial drugs-Bakuchi Compound 5gm twice a day and KhadiraKwatha 40 ml twice daily orally for 60 days. |
| Comparator Agent |
no comparator Agent |
no Comparator Agent |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
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. |
|
| ExclusionCriteria |
| Details |
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.
|
|
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Method of Generating Random Sequence
|
Computer generated randomization |
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Method of Concealment
|
Not Applicable |
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Blinding/Masking
|
Open Label |
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Primary Outcome
|
| Outcome |
TimePoints |
Primary outcome: Assessment of changes in specific signs and symptoms of shwitra
Secondary outcome: Any adverse effect in the values of haematological test and in clinical signs and symptoms. |
60 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Any adverse effect in the values of haematological test and in clinical signs and symptoms. |
60 days |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
Final Enrollment numbers achieved (Total)= "28"
Final Enrollment numbers achieved (India)="28" |
|
Phase of Trial
|
Phase 2 |
Date of First Enrollment (India)
Modification(s)
|
31/10/2019 |
| Date of Study Completion (India) |
20/04/2020 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
No |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
Modification(s)
|
The disease Shwitra is posing big
challenge to the medical world. Although the disease is known to all since
long-back, but no satisfactory treatment protocol is available for management
in contemporary medical sciences. All age group people are affected from this
disease. Ayurveda management seems to be more satisfactory because of
their long lasting effects and multiple systematic regenerative actions
without any harm. Previously no research work has been done with this trial
drugs “Bakuchi compound and khadira kwatha†with
and without virechana. So, the present study has been planned
to provide an effective, cost effective treatment for shwitra (vitiligo) by
using Ayurveda principle.
STUDY
DESIGN:
Study type-Interventional
Purpose –Treatment
Masking –Open label
Timing- Prospective
Administration
of Drugs:- The 60
clinically diagnosed patient of Shwitra will be equally divided into two
groups.
Group A– 15
Patients will be administered trial drugs- “Bakuchi Compound†5gm
twice a day and“Khadira Kwathaâ€40 ml twice daily orally for 60 days.
Group B-Patients of this group will be
performed Virechanakarma before the trial drugs-“Bakuchi Compoundâ€
5gm twice a day and “Khadira Kwathaâ€40 ml twice daily orally for 60
days.
Patient
will be assessed clinically on 1st day, 30th day
and 60th day i.e. at the end of the trial
Result
of the trial:
Results
in patients of Group A: In Group A, patients treated with “Bakuchi Compound†and “Khadira Kwatha†showed percentage
wise improvement in subjective parameters 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 or
statistically. It showed non-significant result (p value >0.05). In case of objective parameters, percentage wise improvement was found in the
size of the patches where the mean score before treatment was 37.15
which decreased to 33.38, giving a
decrement of 10.12 % which was statistically highly- significant (p<0.01). Colour of the skin showed statistically highly significant
result where the mean score before treatment was 1.38 which was increased to
2.15 (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). In
case of Lab. Investigations, there were no statistically significant changes
found in any of the variables.
Results in
patients of Group B: In
Group B, patients treated with Virechana
Karma prior to administration of
the same trial drugs “Bakuchi Compoundâ€
and “Khadira
Kwathaâ€. It showed percentage wise improvement in subjective
parameters 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 or
statistically. In case of objective parameters, percentage wise improvement was found in the size of the patches which
was statistically highly- significant.
The mean score before treatment was 42.26 which decreased to 28.00 after
treatment, giving relief of 33.76% which was statistically highly-significant (p<0.001). In
case of the colour of the skin, the mean score before treatment was 1.33 which
was increased to 2.86 (as the colour improvement score was in ascending order)
after treatment, with a relief of
53.3% 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). No
significant changes were found in any other haematological or bio-chemical
variables.
Intergroup
comparison:
On intergroup comparison there was no statistically significant difference in
all subjective parameters. In objective
parameters, the size of the patches showed statistically highly-significant (p<0.01) result. The p value 0.041 (p<0.05) was
found on intergroup comparison in colour change, which was statistically
significant, that means there was difference in efficacy of both the treatments
on Shwitra.
Conclusion:
The result of
both therapies was statistically highly significant in reducing the size of
patch and change of colour in both the groups. The patient of Group-B where Virechana was performed showed better
result in both subjective and objective parameters than Group-A. It signifies the
importance of Shodhana Chikitsa in Shwitra. So, according to classical text, repeated
use of Shodhana therapy may bring significant result in the
treatment of this disease. Therapy was well tolerated by all the patients.
There were no adverse effects or complications found during the trial period. The
study has revealed that there was no adverse effect on renal and liver
function test. Thus, finally it can be concluded that the drug “Bakuchi Compound†and “Khadira Kwatha†is
safe, cost effective & free from any side effects in the management of Shwitra.
.
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