| CTRI Number |
CTRI/2023/02/049993 [Registered on: 22/02/2023] Trial Registered Prospectively |
| Last Modified On: |
04/01/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Other (Specify) [AVAGAHA SWEDA (HOT SITZ BATH)] |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A Study of Nirgundi Patra decoction sitz bath as an add-on therapy in wound healing of post-operative Ano-Rectal surgical wounds. |
|
Scientific Title of Study
|
A Randomized controlled trial to evaluate the efficacy of Nirgundi Patra Kwatha Avagaha Sweda (sitz bath) as an add-on therapy in wound healing of post-operative Ano-Rectal surgical wounds. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Hemil Kumudchandra Patel |
| Designation |
MS Scholar Shalyatantra |
| Affiliation |
Dr D Y Patil college of Ayurved and Research centre Pimpri Pune |
| Address |
OPD no 3 Shalyatantra department Dr D Y Patil college of Ayurved and Research centre Pimpri Pune 18
Pune
MAHARASHTRA
411018
India |
| Phone |
7229002770 |
| Fax |
|
| Email |
patelhemil5656@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Atul Patil |
| Designation |
Associate Professor Shalyatantra |
| Affiliation |
Dr D Y Patil college of Ayurved and Research centre Pimpri Pune |
| Address |
OPD no 3 Shalyatantra department Dr D Y Patil college of Ayurved and Research Centre Pimpri pune 18
Pune
MAHARASHTRA
411018
India |
| Phone |
9405659585 |
| Fax |
|
| Email |
dratulpatil85@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Atul Patil |
| Designation |
Associate Professor Shalyatantra |
| Affiliation |
Dr D Y Patil college of Ayurved and Research centre Pimpri Pune |
| Address |
OPD no 3 Shalyatantra department Dr D Y Patil college of Ayurved and Research centre Pimpri Pune 18
Pune
MAHARASHTRA
411018
India |
| Phone |
9405659585 |
| Fax |
|
| Email |
dratulpatil85@gmail.com |
|
|
Source of Monetary or Material Support
|
| DR D Y PATIL COLLEGE OF AYURVED AND RESEARCH CENTRE PIMPRI PUNE 18
DEEMED TO BE UNIVERSITY |
|
|
Primary Sponsor
|
| Name |
DR HEMIL KUMUDCHANDRA PATEL |
| Address |
OPD NO 3 SHALYATANTRA DEPARTMENT DR D Y PATIL COLLEGE OF AYURVED AND RESEARCH CENTRE PIMPRI PUNE 18 SANT TUKARAM NAGAR |
| 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 Hemil KUMUDHANDRA PATEL |
DR D Y PATIL COLLEGE OF AYURVED AND RESEARCH CENTRE PIMPRI PUNE 18 |
OPD NO 3 SHALYATANTRA DEPARTMENT Dr D Y PATIL COLLEGE OF AYURVED AND RESEARCH CENTRE PIMPRI PUNE 18 SANT TUKARAM NAGA R
Pune
MAHARASHTRA |
7229002770
patelhemil5656@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Research and Recognition Commitee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:T889||Complication of surgical and medical care, unspecified. Ayurveda Condition: VRANA-APACARAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | avagAhasvedaH, अवगाहसà¥à¤µà¥‡à¤¦à¤ƒ | (Procedure Reference: Sushruta Samhita, Procedure details: To prepare a sitz bath, fill a tub with Nirgundi Patra Kashaya.so that, Kashaya covers the hip. The temperature of Drava Dravyas will be adjust to 42 degree celsius with thermometer.The patient will be made to seat with his leg apart and place outside the tub. The patient will be advise to maintain the position for 20 minutes twice daily for 7 days with post operative treatment protocol.)
| | 2 | Comparator Arm (Non Ayurveda) | | - | Post-operative management | Hot sitz bath twice a day with post operative treatment protocol. |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1. Post-operative Ano-Rectal surgical wound of Fissure in Ano, Fistula in Ano, Haemorrhoids.
2. shopha (Inflammation)
3. shool (Pain)
4. Sraav (Discharge)
5. Kandu (Itching) |
|
| ExclusionCriteria |
| Details |
1. Disorders of particularly Knee and Hip.
2. Guda Arbuda.
3. Skin diseases.
4. HIV, HBsAg. |
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate the efficacy of Nirgundi Patra Kwatha as wound healing action in post-operative Ano-Rectal surgical wounds. |
Nirgundi Patra Kwatha Avagaha Sweda for 20 minutes daily twice a day for 7 days.
Follow up will be on 1st, 4th and 7th day.
Total duration of study will be 7 days.
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To access the Shoolaghna (analgesics), Krimighna (anti-microbial) and Shophaghna (anti-inflammatory) effect of Nirgundi Patra Kwatha in post-operative Ano-Rectal surgical wound. |
Nirgundi Patra Kwatha Avagaha Sweda for 20 minutes daily twice a day for 7 days.
Follow up will be done on 1st, 4th and 7th day.
Total duration of study will be 7 days. |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
15/03/2023 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Total 60 patients will be selected from IPD of our institute. They will be divided into 2 groups each consisting of 30 patients. This is an add-on therapy in which Trial group will be given by post-operative management of Ano-Rectal surgical wound with Nirgundi Patra Kwatha Avagaha Sweda and Comparative group will be given by post-operative management of Ano-Rectal surgical wound. Assessment and follow will be done on 1st, 4th and 7th day.The study duration will be of 7 days. |