| CTRI Number |
CTRI/2021/09/036968 [Registered on: 29/09/2021] Trial Registered Prospectively |
| Last Modified On: |
25/09/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To see the effect of khadirashtak kwath ghan vati in the treatment of vicharchika (skin disease) |
|
Scientific Title of Study
|
Randomised controlled clinical trial to evaluate efficacy between “Khadirashtak kwath ghanvati†with tab. Takzema in the management of “Vicharchikaâ€.
|
| Trial Acronym |
RKTV |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Rameshwar Vaijinath Jadhav |
| Designation |
PG Scholar |
| Affiliation |
PDEAs College of Ayurved and Research centre ,Nigdi ,Pune. |
| Address |
PDEAs College of Ayurved and Research centre ,Third floor , Kayachikitsa Department, Sector no.- 25,Nigdi praadhikaran ,Pune.
PDEAs College of Ayurved and Research centre ,Third floor , Kayachikitsa Department, Sector no.- 25,Nigdi praadhikaran ,Pune.
Pune
MAHARASHTRA
411044
India |
| Phone |
9921270826 |
| Fax |
|
| Email |
ramvjadhav1910@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DrSurekha Anantrao Atram |
| Designation |
Asso. Profesor of kayachikitsa Department |
| Affiliation |
PDEAs College of Ayurved and Research centre ,Nigdi ,Pune |
| Address |
PDEAs College of Ayurved and Research centre ,Third floor , Kayachikitsa Department, Sector no.- 25,Nigdi praadhikaran ,Pune.
PDEAs College of Ayurved and Research centre ,Third floor , Kayachikitsa Department, Sector no.- 25,Nigdi praadhikaran ,Pune.
Pune
MAHARASHTRA
411044
India |
| Phone |
749893921 |
| Fax |
|
| Email |
atramsurekha@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Rameshwar Vaijinath Jadhav |
| Designation |
PG Scholar |
| Affiliation |
PDEAs College of Ayurved and Research centre ,Nigdi ,Pune |
| Address |
PDEAs College of Ayurved and Research centre ,Third floor , Kayachikitsa Department, Sector no.- 25,Nigdi praadhikaran ,Pune.
PDEAs College of Ayurved and Research centre ,Third floor , Kayachikitsa Department, Sector no.- 25,Nigdi praadhikaran ,Pune.
Pune
MAHARASHTRA
411044
India |
| Phone |
9921270826 |
| Fax |
|
| Email |
ramvjadhav1910@gmail.com |
|
|
Source of Monetary or Material Support
|
| PDEAs College of Ayurved and Research centre ,Third floor , Kayachikitsa Department, Sector no.- 25,Nigdi praadhikaran ,Pune. |
|
|
Primary Sponsor
|
| Name |
PDEAs College of Ayurved and Research centre Nigdi Pune |
| Address |
PDEAs College of Ayurved and Research centre ,Third floor , Kayachikitsa Department, Sector no.- 25,Nigdi praadhikaran ,Pune. |
| Type of Sponsor |
Private medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Rameshwar Vaijinath Jadhav |
Ayurved Rugnalay and Sterling Multispecility Hospital |
Ayurved Rugnalay and Sterling Multispecility Hospital, Kayachikitsa OPD-117, Ground floor,Nigdi pradhikaran ,PCMC pune 411044
Pune
MAHARASHTRA |
9921270826
ramvjadhav1910@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
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:L309||Dermatitis, unspecified. Ayurveda Condition: Local infection of the skin and subcutaneous tissue, unspecified , |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Tab.Takzema (charak pharma)
|
Group B will be treated with Tab.Takzema 500mg BD in vyanodane kaal with koshn jal in 18 to 60 year age group in 1 month which includes follow up on 15th and 30th day.
|
| Intervention |
Khadirashtak Kwath Ghanavati
|
Group A will be treated with Khadirashtak Kwath Ghanavati 500mg BD in vyanodane kaal with koshn jal in 18 to 60 year age group for 1 month which includes follow up on 15th and 30th day. .
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients with clinical features of Vicharchika having signs and symptoms namely Kandu(itching),Pidaka(Eruption),Vaivarnya(Depigmentation) and Srava (Discharge).
|
|
| ExclusionCriteria |
| Details |
Patient having severe systemic diseases or condition along with Vicharchika and
Pregnant & Lactating woman. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
To evaluate the efficacy of khadirashtak kwath ghanvati 500mg BD in vyanodane kaal with koshn jal for 1 month and tab. Takzema 500 mg BD in vyanodane kaal with koshn jal in the manegment of vicharchika.
|
One month with follow up on 15th and 30th day. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To compare and study the efficacy of khadirashtak kwath ghan vati .
To compare and study the efficacy of tab. Takzema
To observe the adverse effects, if any. |
One month with follow up on 15th and 30th day. |
|
|
Target Sample Size
|
Total Sample Size="66"
Sample Size from India="66"
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
|
N/A |
|
Date of First Enrollment (India)
|
12/10/2021 |
| 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="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Not yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
In current medical scenario one can observe increase in patients having skin disorders.some patients get relief after treatment but some get it again with some time interval or after certain duration of treatment. In Ayurveda all skin diseases are grouped under broad heading of kushtha roga and it is divided in to mahakushtha and kshudra nishtha. Vicharchika is a type of kshudrakushtha a chronic disease which analogues to eczema in modern medical science, which inculdes sign and symptoms of kandu(itching), Piddika,Bahusrava,Shyavavarnata etc. Khadirashtak kwath ghanvati mentioned in Yogratnakr in kashtha chikitsa adhyay, drug is having kushthaghn,kandughn,krimighn and tridoshghn properties,hence this drug will be used in Vicharchika. |