| CTRI Number |
CTRI/2024/04/065510 [Registered on: 10/04/2024] Trial Registered Prospectively |
| Last Modified On: |
08/04/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Study of Vipadikahara Ghrita- Taila Malahara in Vipadika |
|
Scientific Title of Study
|
Pharmaceutico- Clinical Study Of Vipadikahara Ghrita-Taila(Malahara) W.S.R. To Vipadika |
| 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 Krishna Kant Singh |
| Designation |
MD Scholar Rasa Shastra and Bhaishajya Kalpana |
| Affiliation |
Sampurnanand Sanskrit University Varanasi |
| Address |
Govnrnment P G Ayurvedic College and Hospital Varanasi Uttar Pradesh
Government P G Ayurvedic College and Hospital Varanasi Uttar Pradesh
Varanasi
UTTAR PRADESH
221002
India |
| Phone |
9450666526 |
| Fax |
|
| Email |
kkayurveda1982@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Krishna Kant Singh |
| Designation |
MD Scholar Rasa Shastra and Bhaishajya Kalpana |
| Affiliation |
Sampurnanand Sanskrit University Varanasi |
| Address |
Govnrnment P G Ayurvedic College and Hospital Varanasi Uttar Pradesh
Government P G Ayurvedic College and Hospital Varanasi Uttar Pradesh
Varanasi
UTTAR PRADESH
221002
India |
| Phone |
9450666526 |
| Fax |
|
| Email |
kkayurveda1982@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Krishna Kant Singh |
| Designation |
MD Scholar Rasa Shastra and Bhaishajya Kalpana |
| Affiliation |
Sampurnanand Sanskrit University Varanasi |
| Address |
Govnrnment P G Ayurvedic College and Hospital Varanasi Uttar Pradesh
Government P G Ayurvedic College and Hospital Varanasi Uttar Pradesh
Varanasi
UTTAR PRADESH
221002
India |
| Phone |
9450666526 |
| Fax |
|
| Email |
kkayurveda1982@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government P.G. Ayurvedic College and Hospital Varanasi |
|
|
Primary Sponsor
|
| Name |
Government P.G. Ayurvedic College and Hospital Varanasi |
| Address |
Department of Rasa Shastra and Bhaishajya Kalpana Government P.G. Ayurvedic College and Hospital Varanasi Uttar Pradesh |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Ankit Kumar Gupta |
Government P G Ayurvedic College & Hospital Varanasi |
OPD No 5 Department of Rasa Shastra & Bhaishajya Kalpana and OPD No 20 Department of Swasthvritta Government P G Ayurvedic College & Hospital Varanasi Uttar Pradesh
Varanasi
UTTAR PRADESH |
9532016160
drankitg01@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Government P G Ayurvedic College & Hospital Varanasi,UP,Sampurnanand Sanskrit University,Varanasi,UP |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:L088||Other specified local infections of the skin and subcutaneous tissue. Ayurveda Condition: VIPADIKA, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Vipadikahara Ghrit-Taila (Malahara), Reference: Charak Chikitsa 7/120-121, Route: Topical, Dosage Form: Malahara/ Ointment/ Balm, Dose: 8(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 1 Months, anupAna/sahapAna: No, Additional Information: N/A |
|
|
|
Inclusion Criteria
|
| Age From |
16.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients having clinical sign and symptoms of vipadika. |
|
| ExclusionCriteria |
| Details |
1-Patients below the age of 16 years & above 16 years of age.
2-Patients suffering from chronic skin diseases like any fungal infection, bacterial infection etc.
3-Patients under long term steroids & cytotoxic treatments.
4-Patients of D.M.
5- Patients with evidence of malignancy. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Improvement in cracked Heels |
30 Days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Reduced roughness,cracks & pain |
2 weeks |
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
25/04/2024 |
| 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="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
|
Interventional Study
Patient suffering from cracked heels will selected from OPD of Govt. P G Ayurvedic College & Hospital Varanasi
Total Patient=30
Treatment Plan :-Vipadikahara Grita- Taila (Malahara) wil apply twice daily on the affected area in thin coating twice daily topically
Follow up study :- Every 7 th day for 1 month |