| CTRI Number |
CTRI/2024/10/074796 [Registered on: 07/10/2024] Trial Registered Prospectively |
| Last Modified On: |
04/10/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A clinical study on management of swithra |
|
Scientific Title of Study
|
A Clinical Study on the Efficacy of Swetha Kusthahara Churnam (Internally) and Panchanana Thailam (Externally) with or without Jalaukavacharana in the management of Swithra WSR to Vitiligo |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Karri Lakshmi Anusha |
| Designation |
Post Graduate in Kaya chikitsa |
| Affiliation |
Dr. BRKR Government Ayurvedic college and hospital |
| Address |
KC OPD, Room No. 3, Division unit no. 3,
Dr BRKR Government Ayurvedic college and hospital, Erragadda, Hyderabad.
KC OPD, Room No. 3, Division Unit No. 3,
Dr BRKR Govt. Ayurvedic Medical College and Hospital,
Erragadda, Hyderabad.
Hyderabad
TELANGANA
500038
India |
| Phone |
8074748826 |
| Fax |
|
| Email |
lovelyanusha799@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr A Swaroopa |
| Designation |
MD Ayurveda Department of Kaya Chikitsa |
| Affiliation |
Dr BRKR Government Ayurvedic college and hospital |
| Address |
KC OPD Room no 3,Division unit 3 ,
Dr BRKR Government Ayurvedic medical college and hospital,Erragadda, Hyderabad
KC OPD Room no 3,Division unit 3
DR. BRKR Government Ayurvedic medical college and hospital, Erragadda, Hyderabad.
Hyderabad
TELANGANA
500038
India |
| Phone |
9866275613 |
| Fax |
|
| Email |
swaroopa.kusuma95@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr A Swaroopa |
| Designation |
MD Ayurveda Department of Kaya Chikitsa |
| Affiliation |
Dr BRKR Government Ayurvedic college and hospital |
| Address |
KC OPD Room no 3
Division unit 3
Dr BRKR Government Ayurvedic medical college and hospital,Erragadda.Hyderabad
KC OPD Room no 3
Division unit 3
Dr BRKR Government Ayurvedic medical college and hospital,Erragadda.Hyderabad
Hyderabad
TELANGANA
500038
India |
| Phone |
9866275613 |
| Fax |
|
| Email |
swaroopa.kusuma95@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr BRKR Government Ayurvedic medical college and hospital, Erragadda
Hyderabad Telangana
Pin code 500018
India
|
|
|
Primary Sponsor
|
| Name |
Dr Karri Lakshmi Anusha |
| Address |
Room no 3
Kayachikitsa OPD
Dr. BRKR Government Ayurvedic college and hospital,Erragadda |
| 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 Karri Lakshmi Anusha |
Dr. BRKR Government Ayurvedic college and hospital |
Room no 3
Kaya Chikitsa OPD
Dr.BRKR Government Ayurvedic college and hospital,Erragadda
Hyderabad
TELANGANA |
8074748826
lovelyanusha799@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee of Dr BRKR Government Ayurvedic college and hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:L80||Vitiligo. Ayurveda Condition: SVITRAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Procedure | - | jalaukAvacaraNam, जलौकावचरणमॠ| (Procedure Reference: Acharya sushruta, Procedure details: Administrating jalauka on the affected site once in 10 days for 3 months)
(1) Medicine Name: Swetha kushta hara churna, Reference: Rasa ratna samuchaya, Route: Oral, Dosage Form: Churna/ Powder, Dose: 6(g), Frequency: bd, Duration: 3 Months | | 2 | Comparator Arm | Drug | Classical | | | | 3 | Comparator Arm | Procedure | - | pracCAnam, पà¥à¤°à¤šà¥à¤›à¤¾à¤¨à¤®à¥ | (Procedure Reference: Bhaishajya Ratnavali, Procedure details: Prachana is done on lesion and apply externally oil (panchanana thailam) )
|
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients with sadhya lakshanas of swithra (Twak swethata, kandu, daha, roma vivarnata)
2.Patients with lesions of normal sensation of touch. |
|
| ExclusionCriteria |
| Details |
Burns and traumatic incidents are excluded.
Lesions over genitals lips and mucosal memberanes are excluded.
Malignant melanoma, Albinism are excluded.
Patients having lesions more than seven years
Patients with other disease like SLE,Pernicious anaemia.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Decreasing the size of lesions. |
90 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To evaluate the effect of swetha kushta hara churna panchanana thailam,
Jalaukavacharana in management of Vitiligo |
90 days |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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 |
|
Date of First Enrollment (India)
|
15/10/2024 |
| 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
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Skin is the largest organ in human body. It is a best indicator of good health. Skin diseases are one which are visible and agonizing the individual psycho Somatically. Swithra is one mentioned in ayurveda as Kushta roga. It is tridoshaja vikara with involvement of rasa rakta mamsa medho dhatus. Brajaka pitta and udana vata vitiation due to nidana can cause swithra. Swithra is a disease compared with vitiligo. It is characterized by Depigmented Or hypopigmented patches of the skin. It is most common pigmentation disorder affecting World Wide. The study is done with a intention to find out safe and effective treatment using swethakustahara churnam and panchanana taila along with or without Jalaukavacharana in management of swithra. |