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CTRI Number  CTRI/2020/10/028366 [Registered on: 13/10/2020] Trial Registered Prospectively
Last Modified On: 09/10/2020
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Effectiveness of Bakuchikadyam Choorna orally and Manashiladi tailam topically in the management of Vicharchika(Eczema) 
Scientific Title of Study   Randomized controlled clinical study to evaluate the efficacy of Bakuchikadyam Choorna orally and Manashiladi tailam topically in the management of Vicharchika(Eczema) 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Pravin Kendre 
Designation  PG Scholar 
Affiliation  DMM Ayurved Mahavidyalaya Yavatmal 
Address  JAy Yogeshwar Nivas Mannath Nagar opposit yadnyabhumi Gangakhed Tal Gangakhed dist Parbhani
DMM Ayurved Mahavidyalaya shivaji Ground Arni road yavatmal
Parbhani
MAHARASHTRA
431514
India 
Phone  8805324142  
Fax    
Email  pravinkendre5@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Subhash Jamdhade 
Designation  Associate Professor 
Affiliation  DMM Ayurved Mahavidyalaya Yavatmal 
Address  PRADNYASURYA 23 Dahivalkar layout Date College Chowk Yavatmal
DMM Ayurved Mahavidyalaya shivaji Ground Arni road yavatmal
Yavatmal
MAHARASHTRA
445001
India 
Phone  9822201196  
Fax    
Email  drsubhashjamdhade@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Subhash Jamdhade 
Designation  Associate Professor 
Affiliation  DMM Ayurved Mahavidyalaya Yavatmal 
Address  PRADNYASURYA 23 Dahivalkar layout Date College Chowk Yavatmal

Yavatmal
MAHARASHTRA
445001
India 
Phone  9822201196  
Fax    
Email  drsubhashjamdhade@gmail.com  
 
Source of Monetary or Material Support  
DMM Ayurved Mahavidyalaya Yavatmal 
 
Primary Sponsor  
Name  DMM Ayurved Mahavidyalaya Yavatmal 
Address  DMM Ayurved Mahavidyalaya Shivaji Nagar Arni Road Yavatmal 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr pravin kendre  DMM Ayurved Mahavidyalaya Yavatmal  Shivaji Ground Arni Road Yavatmal
Yavatmal
MAHARASHTRA 		 8805324142

pravinkendre5@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: L208||Other atopic dermatitis,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Aarogyavardhini gutika And Karanjadi Tailam  Aarogyavardhini gutika 250mg twice a day for 45 Days. And Karanjadi Tailam local Application twice a Day for 45 Days 
Intervention  Bakuchikadyam choorna And Manashiladi Tailam  Bakuchikadyam choorna Orally 3gm twice a day for 45 Days. And Manashiladi Tailam local application twice a day for 45 Days. 
 
Inclusion Criteria  
Age From  16.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  1) Age group above 16 and below 70 years.
2) patient having classical signs and symptoms of vicharchika,
a) Kandu (itching)
b) Pidika (eruption)
c) Syava varna (blackish discolouration)
d) Strava (discharge)
e) Ruja (pain)
f) Rajyo (marked lining due to thickness of lesion)
g) Rukshata(dryness)
h) lohit varna (redness of lesion )
3) Patient willing for clinical trial.
4) Irrespective of gender, occupation, Religion, economical barrier.
5) patients willing to participate.
6) patients who will fulfil criteria and take regular medicines with
regular follow up.
 
 
ExclusionCriteria 
Details  1) Age group below 16 years and above 70 years .
2) Pregnant and lactating mother.
3) Infective origins like
a)Koch‘s
b) Hansen‘s disease
c) Scabies
d) Fungal infection /herpes zoster.
4) Drug induced eczema.
5) Immune compromised like HIV,HBV
6) Systemic disorders DM,CVV
7) Diabetic wound
8) Renal diseases like CKD
9) Endocrine disorders will exclude from study to avoid over lapping
of symptoms. 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To study the therapeutic effect of oral administration of Bakuchikadyam Choorna and topical application of Manashiladi tailam.
 		 7th 14th 21th 28th 35th 45th day
 
 
Secondary Outcome  
Outcome  TimePoints 
1) To study the disease Vicharchika and Eczema
2) To see the effect of
oral administration of Bakuchikadyam Choorna and topical application of Manashiladi tailam in signs and symptoms of vicharchika i.e 1)Kandu
2)Shyava varna
3)Pidika
4)Bahu strava
5)Ruja
6)Rajyo
7)Rukshata
8) Lohit varna
3) To compare the effect of Bakuchikadyam Choorna and of Manashiladi tailam with Aarogyavardhini gutika and Karanjadi tailam in the management Vicharchika . 		 7th 14th 21th 28th 35th 45th day
 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Phase 2/ Phase 3 
Date of First Enrollment (India)   15/10/2020 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="12"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   NIL 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

Introduction

Skin is the largest and important organ and outermost covering of the body which acts as a protective barrier.But very often, it is exposed to many entities which can damage it and cause many of the skin disorder. About 10-20% of the general practice includes the patients suffering from skin disorder and Eczema accounts for a very large proportion of all the skin diseases

In Ayurveda, The word Kushta is broad term, which covers almost all skin disorders.

“kushnatee iti kushtham”

(Ma.Ni./Kushta./Tika 1)

According to Astang hrudaya,in kushta due to vitiated dosha the part of skin becomes affected and changes its normal colour called kushtha.

Which have been classified mainly into two groups-

Viz.

(1) Mahakushtha (2) Kshudrakushtha 

Vicharchika being one among kshudrakushtha,is also a Rasa,Rakta and Mansa dhatu pradoshaj vikara

 

According to charak samhita,vicharchika is kaphapradhan vyadhi.[6] and symptoms of vicharchika are kandu(Itching), shyava varna(blackish discolouration), pidika(eruption), bahustrava(discharge), ruja (pain), rajyo (marked lining due to thickness of lesion ), rukshata(dryness),lohit varna(redness of lesion).[5,6,10]

Also Many Acharya defined as various dosha responsible for Vicharchika vyadhi and defined vicharchika is kaphapradhan, pittapradhan, Kaphavatpradhan Disease.

 purpose of study:- To study the therapeutic effect of oral administration of Bakuchikadyam choorna and topical application of Manashiladi tailam.

OBJECTIVE:

PRIMARY OBJECTIVE: To study the therapeutic effect of oral administration of Bakuchikadyam choorna and topical application of Manashiladi tailam.

 

SECONDARY OBJECTIVE: 1) To study the disease Vicharchika and Eczema .

 

2)To see the effect of Bakuchikadyam choorna and Manashiladi tailam in signs and symptoms of vicharchika i.e

1)Kandu

2)Shyava varna

3)Pidika

4)Bahu strava

5)Ruja

6)Rajyo

7)Rukshata

8)Lohit varna

 

3) To compare the effect of Bakuchikadyam choorna and Manashiladi tailam with Aarogyavardhini gutika and Karanjadi tailam in the management of Vicharchika.

 

Point for RCT :-

1) Randomized proposed

Simple randomized control trial

2) Allocation concealment proposed:-

Patient will be randomly allocated in intervention group with the help of Lottory method.

3)Blinding proposed :- Not applicable .

 

Sample size :- 60 patients 

30 patients in each group 

1) 30 patients in intervention group.(Group –A)

2) 30 patients in controlled group.(Group – B)

 

GROUPING AND DRUG DELIVERY REGIMEN: 

Group-A (Trial group)- Bakuchikadyam choorna 3gm orally twice a day  and Manashiladi tailam local application twice a day for 45 days

Group-B (Control group)- Aarogyavardhini gutika 250mg orally twice a day and Karanjadi tailam  local application twice a day for 45 days

 

Time for drug administration :- 45 days

 
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