| CTRI Number |
CTRI/2023/07/055489 [Registered on: 21/07/2023] Trial Registered Prospectively |
| Last Modified On: |
10/07/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
1.Treatment of Vipadika Kushta(palmoplantar psoriasis) by the application of Tila Taila.
2. Treatment of Vipadika Kushta (Palmoplantar Psoriasis) by the application of Tilakusumadi Lepa. |
|
Scientific Title of Study
|
Concept of Upashaya with special reference to Vipareeta Aushadha in the Management of Vipadika Kushta - A Randomized Clinical Study |
| 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 Sudha Mantur |
| Designation |
PG Scholar |
| Affiliation |
Sri Sri College of Ayurvedic Science and Research, Bengaluru |
| Address |
Department of PG Studies in Ayurveda Samhita and Siddhanta, Sri Sri College of Ayurvedic Science and Research, 21st km Kanakapura Road Udayapura Post Bengaluru
Bangalore Rural
KARNATAKA
560082
India |
| Phone |
8197073879 |
| Fax |
|
| Email |
sudhamantur879@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ranjith Kumar Shetty |
| Designation |
Associate Professor |
| Affiliation |
Sri Sri College of Ayurvedic Science and Research, Bengaluru |
| Address |
Department of PG Studies in Ayurveda Samhita and Siddhanta, Sri Sri College of Ayurvedic Science and Research, 21st km Kanakapura Road Udayapura Post Bengaluru
Bangalore Rural
KARNATAKA
560082
India |
| Phone |
9964317529 |
| Fax |
|
| Email |
drranjithayu@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sudha Mantur |
| Designation |
PG Scholar |
| Affiliation |
Sri Sri College of Ayurvedic Science and Research, Bengaluru |
| Address |
Department of PG Studies in Ayurveda Samhita and Siddhanta, Sri Sri College of Ayurvedic Science and Research, 21st km Kanakapura Road Udayapura Post Bengaluru
Bangalore Rural
KARNATAKA
560082
India |
| Phone |
8197073879 |
| Fax |
|
| Email |
sudhamantur879@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sri Sri College of Ayurvedic Science and Research, 21st km Kanakapura Road Udayapura Post Bengaluru |
|
|
Primary Sponsor
|
| Name |
Dr Sudha Mantur |
| Address |
Department of PG Studies in Ayurveda samhita and siddhanta, Sri Sri College of Ayurvedic Science and Research, 21st km Kanakapura Road Udayapura Post Bengaluru |
| 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 Sudha Mantur |
Sri Sri College of Ayurvedic Science and Research, Bengaluru |
Department of PG Studies in Ayurveda Samhita and Siddhanta, Sri Sri College of Ayurvedic Science and Research, 21st km Kanakapura Road Udayapura Post Bengaluru
Bangalore Rural
KARNATAKA |
8197073879
sudhamantur879@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SRI SRI INSTITUTIONAL ETHICAL COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:L403||Pustulosis palmaris et plantaris. Ayurveda Condition: Vipadika Kushta, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | lepa, लेप | (Procedure Reference: charaka samhita, Procedure details: Subjects are asked to wash their hands and/or feet with warm water & wipe them with a clean cloth.
later,Tila taila is given for application to a group A subjects, over the affected area.
The application will be applied once daily at 10 p.m., removed at 6 a.m. & kept in contact with the skin.
)
(1) Medicine Name: Tila Taila, Reference: Charaka Samhita, Route: Topical, Dosage Form: Taila, Dose: 10(ml), Frequency: od, Duration: 15 Days | | 2 | Comparator Arm | Procedure | - | lepa, लेप | (Procedure Reference: Vaidya Yoga Ratanavali, Procedure details: • Subjects are asked to wash their hands and/or feet with warm water & wipe them with a clean cloth.
Later, Sindhooradi lepa is given for application to the group B subjects, over the affected area.
The application will be applied once daily at 10 p.m., removed at 6 a.m., and kept in contact with the skin.
)
(1) Medicine Name: Sindhooradi lepa, Reference: Vaidya Yoga Ratanavali, Route: Topical, Dosage Form: Malahara/ Ointment/ Balm, Dose: 10(g), Frequency: od, Duration: 15 Days | | 3 | Intervention Arm | Procedure | - | lepa, लेप | (Procedure Reference: Bhaisajyaratnavali , Procedure details: Subjects are asked to wash their hands and/or feet with warm water & wipe them with a clean cloth.
Later,Tilakusumadi lepa is given for application to the group C subjects, over the affected area.
The application will be applied once daily at 10 p.m., removed at 6 a.m., and kept in contact with the skin. )
(1) Medicine Name: Tilakusumadi Lepa, Reference: Bhaisajyaratnavali , Route: Topical, Dosage Form: Malahara/ Ointment/ Balm, Dose: 10(g), Frequency: od, Duration: 15 Days |
|
|
|
Inclusion Criteria
|
| Age From |
21.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Subjects aged between 21 and 60 years, irrespective of gender, caste, occupation and socio-economic status.
2.subjects with clinical features of cracked feet or cracked palms with or without pain. |
|
| ExclusionCriteria |
| Details |
1. Subjects who develop acute skin toxicity or allergy.
2. Subjects having systemic diseases like Diabetic foot, Cellulitis, Contact dermatitis and other skin diseases. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Decrease the symptoms of vipadika kushta within 15 days. |
0th day,7th day, 15th day,21st day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Healing of the cracks within 20 day. |
0th day,7th day, 15th day,21st day |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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 3 |
|
Date of First Enrollment (India)
|
01/08/2023 |
| 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="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
|
this study is put forward to clinically evaluate the role of Hetu Vipareeta Aushada, Vyadhi Vipareeta Aushadha and Ubhaya Vipareeta Aushadha by using Tila Taila, Sindhooradi Lepa and Tilakusumadi Lepa respectively in the management of Vipadika Kushta.
HYPOTHESIS
Null Hypothesis( H0) = Hetu Vipareeta, Vyadhi Vipareeta and Ubhaya Vipareeta Aushadha have no effective role in the management of Vipadika Kushta.
Alternative Hypothesis (H1) = Hetu Vipareeta, Vyadhi Vipareeta and Ubhaya Vipareeta Aushadha have a role in the management of Vipadika Kushta. |