| CTRI Number |
CTRI/2025/06/088620 [Registered on: 11/06/2025] Trial Registered Prospectively |
| Last Modified On: |
21/05/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To Study the effect of Siravedha and Ghritayavakshar Lepa in the management of Padadari with special reference to Cracked Heels |
|
Scientific Title of Study
|
Randomized controlled clinical trial to study the add on effect of Siravedha along with Ghritayavakshar Lepa in the management of Padadari with special reference to Cracked Heels |
| 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 Sameer Ameer Shaha |
| Designation |
Ph Scholar |
| Affiliation |
LRP ayurvedic medical college and hospital, pg institute and research centre Islampur |
| Address |
Shalyatantra department of LRP ayurvedic medical college and hospital, pg institute and research centre Islampur dist sangli
Sangli
MAHARASHTRA
415409
India |
| Phone |
8381063505 |
| Fax |
|
| Email |
drsamshaha@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rajendra Anandrao Jadhav |
| Designation |
Associate professor in shalyatantra department |
| Affiliation |
LRP ayurvedic medical college and hospital , pg institute and research centre,Islampur |
| Address |
OPD no. 9 shalyatantra department of LRP ayurvedic medical college and hospital, Islampur dist sangli
Sangli
MAHARASHTRA
415409
India |
| Phone |
9890331386 |
| Fax |
|
| Email |
drrajesh86@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Rajendra Anandrao Jadhav |
| Designation |
Associate professor in shalyatantra department |
| Affiliation |
LRP ayurvedic medical college and hospital , pg institute and research centre,Islampur |
| Address |
OPD no. 9 shalyatantra department of LRP ayurvedic medical college and hospital, Islampur dist sangli
Sangli
MAHARASHTRA
415409
India |
| Phone |
9890331386 |
| Fax |
|
| Email |
drrajesh86@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
| LRP ayurvedic medical college and hospital, pg institute and research centre, Islampur dist sangli maharashtra |
|
|
Primary Sponsor
|
| Name |
Dr Sameer Ameer Shaha |
| Address |
Shalyatantra department of LRP ayurvedic medical college and hospital, pg institute and research centre, Islampur dist sangli maharashtra |
| 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 Sameer Ameer Shaha |
LRP ayurvedic medical college and hospital |
OPD no 9, shalyatantra department of LRP ayurvedic medical college and hospital, pg institute and research centre, Islampur dist sangli maharashtra
Sangli
MAHARASHTRA |
8381063505
drsamshaha@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Loknete Rajarambapu Patil ayurvedic medical college institutional committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:L896||Pressure ulcer of heel. Ayurveda Condition: PADADARI, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Procedure | - | lepaH (viShopakramaH), लेपः (विषोपक्रमः) | (Procedure Reference: Sushrut samhita chikitsa sthan adhyay 20, shloka 19,20 , Procedure details: After cleaning feets application of lepa daily at night.)
(1) Medicine Name: Ghriyavkshar lepa , Reference: Sushrut samhita chikitsa sthan adhyay 20, shloka 19, 20 , Route: Topical, Dosage Form: Malahara/ Ointment/ Balm, Dose: 2(mg), Frequency: hs, Duration: 21 Days | | 2 | Intervention Arm | Procedure | - | sirAvedhaH, सिरावेधः | (Procedure Reference: Sushrut samhita chikitsa sthan adhyay 20, shloka 19, 20 , Procedure details: Site clean with betadine swab, Siravedha done with scalp vein set.10 to 15ml of blood letting done.scalp vein set remove and dressing done.)
(1) Medicine Name: Ghriyavkshar lepa , Reference: Sushrut samhita chikitsa sthan adhyay 20, shloka 19, 20 , Route: Topical, Dosage Form: Malahara/ Ointment/ Balm, Dose: 2(mg), Frequency: hs, Duration: 21 Days |
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Patient having age between 20 to 60 years.
2.Patients irrespective of gender, economic class, religion and occupation.
3.Patient having sign and symptoms of padadari will be randomly selected.
|
|
| ExclusionCriteria |
| Details |
1.Known cases of systemic disorders like HIV, Hepatitis B, uncontrolled diabetes mellitus.
2.Patients suffering from skin disorders like psoriasis and foot ulcer.
3.Known cases of Anemia and Haemophilia.
4.Siravedha ayogya like wounded, tired, timid, children etc .
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Study the add on effect of Siravedha along with ghritayavakshar lepa in the management of padadari with special reference to cracked heels in age group of 20 to 60 for 21days.
To reduce the cracks on heels. |
21 days
F/U on 0th, 7th, 14th, 21th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Study the add on effect of Siravedha along with ghritayavakshar lepa in the management of padadari with special reference to cracked heels in age group of 20 to 60 for 21days.
To reduce the cracks on heels. |
15days with f/u on 21th and 28th day. |
|
|
Target Sample Size
|
Total Sample Size="90"
Sample Size from India="90"
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)
|
24/06/2025 |
| 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="0"
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
|
This is Randomized controlled clinical trial to study the add on effect of siravedha along with ghrityavkshar lepa in the management of padadari with special reference to crack heel. siravedha is done to expel the vitiated blood from the site and provide relief. This method is considered to be the effective, quick and economical. Ghrityavkshar formulation contains the ingredients which helps in reducing pain,rukshta, itching.thus promoting healing of cracks. Patient having age group of 20 to 60 years. It will be done on 0th, 7th, 14th, 21th and 28th day. conclusion will be drawn on the basis of the data obtained and observed during the study. |