| CTRI Number |
CTRI/2025/03/081619 [Registered on: 04/03/2025] Trial Registered Prospectively |
| Last Modified On: |
03/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
To study the effect of vaman karma with indrayava in management of kitibha kushta. |
|
Scientific Title of Study
|
A Clinical Study To Evaluate The Efficacy Of Vamana Karma With Indrayava In Management Of Kitibh Kustha |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DrVishnupriya Vinayak Bandwalkar |
| Designation |
MD Scholar |
| Affiliation |
YMT Ayurvedic Medical College and Hospital |
| Address |
Panchakarma department Dr.G.D.Pol Foundation,YMT Ayurvedic college and Hospital,institutional area,Kharghar,Raigarh.
MAHARASHTRA
410210
India
Raigarh
MAHARASHTRA
410210
India |
| Phone |
8237337157 |
| Fax |
|
| Email |
vishnupriyabandawalkar14@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DrAmit chavan |
| Designation |
Associate professor |
| Affiliation |
YMT ayurved medical college and hospital, kharghar, Navi Mumbai. |
| Address |
Panchakarma department Dr.G.D.Pol Foundation,YMT Ayurvedic college and Hospital,institutional area,Kharghar,Raigarh.
MAHARASHTRA
410210
India
Raigarh
MAHARASHTRA
410210
India |
| Phone |
8793263413 |
| Fax |
|
| Email |
vdamitchavan07@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Amit chavan |
| Designation |
Associate professor |
| Affiliation |
YMT ayurved medical college and hospital kharghar Navi Mumbai. |
| Address |
Panchakarma department Dr.G.D.Pol Foundation,YMT Ayurvedic college and Hospital,institutional area,Kharghar,Raigarh.
MAHARASHTRA
410210
India
Raigarh
MAHARASHTRA
410210
India |
| Phone |
8793263413 |
| Fax |
|
| Email |
vdamitchavan07@gmail.com |
|
|
Source of Monetary or Material Support
|
| YMT ayurved medical college and hospital, Panchakarma department, opd and IPD, sector 4,kharghar. Navi Mumbai.
Raigarh
Maharashtra
410210 |
|
|
Primary Sponsor
|
| Name |
Dr Vishnupriya Vinayak Bandwalkar |
| Address |
Panchkarma department,Dr.G.D.Pol Foundation,YMT Ayurvedic college and hospital,institutional area,Kharghar,Raigarh.
MAHARASHTRA
410210
India |
| Type of Sponsor |
Other [Self] |
|
|
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 Vishnupriya Vinayak Bandwalkar |
YMT ayurved medical college and hospital kharghar. |
Group floor OPD patients Dr G D pol foundations YMT ayurved medical college and hospital sector 4 institution area kharghar
Raigarh
MAHARASHTRA |
8237337157
vishnupriyabandawalkar14@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee YMT ayurvedic College |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:L40||Psoriasis. Ayurveda Condition: KITIBAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | Vamana karma | (Procedure Reference: Charak chikitsa sthana adhyay 7 shlok 39, Procedure details: PURVAKRMA –
1) PACHAN – Pachan with Ampachak vati 250mg 2
BD for 5 days .
2) SNEHPAN – Shudha GO –Ghrit in vardhaman
matra till samayak sneh lakshana
3) SARVANG SNEHEN with Tila Taila after
samayak snigdha lakshan are seen on
vishram din & on the vaman day .
4) SWEDANA – Sarvanga Bashpa swed with
dashmool kwath.
5)Patient advised to take Kaphotklesaka Ahara , a day previous to Vamana procedure
(go-dughdh , dahi ,mansras,til,udad)
6)PRADHAN KARM –
Administration of Ghrit Misrita yavagu(
1:6) ratio ,[ 300ml ]
7)Akanthapana by Godughdha 2-3 lits as per
requirement.
8) Patient will be administered vamak yoga
i.e. Indrayava kalp [150 ml]
9)Patient observed for sarvadehika Lakshanas
svedagam,Romharsha,kukshiadamana,hrullas
etc.
10)Patient will be observed for Samayak Vegas , Upavegas .Antiki, Vegiki, Maniki
And Laingiki pariksha will be noted .
11) PASHATAKARMA –
DHUMPANA
11) SANSARJANA KRAMA For 3,5,7 Days according
to Avara , Madhyama & Pravra shudhi.)
(1) Medicine Name: Indrayava , Reference: Raj nighantu .prabhadradi varg.57, Route: Oral, Dosage Form: Kwatha/Kashaya, Dose: 15(g), Frequency: od, Duration: 1 Days |
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1)Patients of kitibha diagnosed by ayurvedic
classics -
a)Shayvam(Greyish discoloration)
b)Kinkharasparsha (Rough like a Scar)
c)Parush (Hardness)
d)Kandu (Itching)
2)Patients who are fit for vamana karma
(vamanarahya)
3)Patients irrespective of gender will be
included and willing for trial. |
|
| ExclusionCriteria |
| Details |
1)Pregnant women and lactating mothers.
2)Patients contraindicated for vamana as per
classical ayurvedic texts.
3)Patients suffering from severe systemic
disorders like cardiac,emphysema,carcinoma
and having history of uncontrolled HTN and
DM.
4)Patients of kitibha, associated with any
other skin disorder like vitiligo,lichen
planus will not be taken under trial.
|
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
To study the effect of vamana karma with indrayava in reducing the symptoms kandu,shyavta,kinkharsparsh,parushta in management of kitibha kushta.
|
Baseline,after vaman and after parihar kaal. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To assess the PASI score before and after vaman karma.
To assess the DLQI score before and after vaman karma. |
Baseline,after vaman and after parihar kaal. |
|
|
Target Sample Size
|
Total Sample Size="29"
Sample Size from India="29"
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)
|
14/03/2025 |
| 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="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Aim: A Clinical study to evaluate the efficacy of vamana karma with Indrayava in the management of kitibh kustha.OBJECTIVES OF THE STUDY – PRIMARY OBJECTIVE - 1] To study the effect of Vamana karma with Indrayava in reducing the Symptoms Kandu, Shyavta , Kinkharsparsh ,Parushta in Management of Kitibha Kushta . 2] To assess PASI score before and after the Vamana Karma . 3] To assess DLQI score before and after the Vamana Karma. SECONDARY OBJECTIVE - 1] To assess Samyak Sign and symptoms of vamana in kitibha. 2] To assess the mode of action of Indrayava in kitibha.
Name of student - Dr. Vishnupriya Vinayak Bandwalkar
Name of Guide- Dr. Amit Chavan.
|