| CTRI Number |
CTRI/2025/01/078922 [Registered on: 17/01/2025] Trial Registered Prospectively |
| Last Modified On: |
17/01/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To evaluate the analgesic effect of patha nirgundi ghrita suppository in post operative pain in ano rectal surgeries |
|
Scientific Title of Study
|
A Randomized Controlled Clinical Trial to Evaluate the Efficacy of Patha (Cissampelos pareira) Nirgundi (Vitex negundo) Ghrita suppository and Paracetamol Suppository in Post Operative Pain in Ano Rectal Surgeries |
| 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 Omkar Tukaram Khatkar |
| Designation |
PG Scholar Shalyatantra |
| Affiliation |
Dr D Y Patil College of Ayurved And Research Centre Pimpri Pune 18 |
| Address |
IPD Shalyatantra of Dr D Y Patil College of Ayurved And Research Centre Sant Tukaram Nagar Pimpri Pune 18
Pune
MAHARASHTRA
411018
India
Pune
MAHARASHTRA
411018
India |
| Phone |
9511858237 |
| Fax |
|
| Email |
omkarkhatkar@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Amit A Paliwal |
| Designation |
M S Ph.D ( Shalyatantra) |
| Affiliation |
Dr D Y Patil College of Ayurved And Research Centre Pimpri Pune 18 |
| Address |
IPD Shalyatantra of Dr D Y Patil College of Ayurved And Research Centre Sant Tukaram Nagar Pimpri Pune 18
Pune
MAHARASHTRA
411018
India
Pune
MAHARASHTRA
411018
India |
| Phone |
8087975164 |
| Fax |
|
| Email |
dramitpaliwal@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Amit A Paliwal |
| Designation |
M S Ph.D ( Shalyatantra) |
| Affiliation |
Dr D Y Patil College of Ayurved And Research Centre Pimpri Pune 18 |
| Address |
IPD Shalyatantra of Dr D Y Patil College of Ayurved And Research Centre Sant Tukaram Nagar Pimpri Pune 18
Pune
MAHARASHTRA
411018
India
Pune
MAHARASHTRA
411018
India |
| Phone |
8087975164 |
| Fax |
|
| Email |
dramitpaliwal@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr D Y Patil College of Ayurved And Research Centre Sant Tukaram Nagar Pimpri Pune 18 |
|
|
Primary Sponsor
|
| Name |
Dr Omkar Tukaram Khatkar |
| Address |
Dr D Y Patil College of Ayurved And Research Centre Sant Tukaram Nagar Pimpri Pune Maharashtra India 411018 |
| 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 Omkar Tukaram Khatkar |
Dr D Y Patil College of Ayurved And Research Centre |
IPD Shalyatantra of Dr D Y Patil College of Ayurved And Research Centre Sant Tukaram Nagar Pimpri Pune 18
Pune
MAHARASHTRA
411018
India
Pune
MAHARASHTRA |
9511858237
omkarkhatkar@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| DR DYPCA AND RC Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:K929||Disease of digestive system, unspecified. Ayurveda Condition: VRANA-UPADRAVAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm (Non Ayurveda) | | - | Paracetamol suppository | Paracetamol suppository will be pushed into the anal verge till it enters into the sphincter. | | 2 | Intervention Arm | Procedure | - | VartiH, वरà¥à¤¤à¤¿à¤ƒ | (Procedure Reference: Sushrata samhita chikitsa sthana 1/55, Procedure details: Varti prepared with patha and nirgundi ghrita suppository will be administered per rectum once a day for 5 day. After 7 days follow up. )
(1) Medicine Name: Patha and nirgundi, Reference: sarth vagbhatt chikitsa sthan 8 ch 63 sholka and kaivvalya nigantu , Route: Rectal, Dosage Form: Varti/ Suppository, Dose: 2(g), Frequency: hs, Duration: 5 Days |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patient experiencing pain post operatively in elective ano rectal surgeries |
|
| ExclusionCriteria |
| Details |
Patients having severe anemia ulcerative colitis crohns disease tuberculosis of the colon and rectum rectal prolapse and rectal cancer will be excluded in the trial |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To study the Vednasthapan effect of patha nirgundi ghrita suppository in the post operative ano rectal surgeries |
First dose of patha nirgundi ghrita suppository will be given on post operative day 0 and will be continue for 5 days and assessment will be done on post operative day 1 to day 5 and follow up after day 7. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To oberverd effect of Per rectal bleeding. |
First dose of patha nirgundi ghrita suppository will be given on post operative day 0 and will be continue for 5 days and assessment will be done on post operative day 1 to day 5 and follow up after day 7. |
|
|
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)
|
05/02/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
05/02/2025 |
| 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
|
On day 1 Patient will be screened from the I.P.D. of Dr. D. Y. Patil College of Ayurved and Research Centre, Pimpri, Pune. Only those patients who will fulfil the eligibility criteria will be enrolled. Patients will be informed about the purpose and the schedule of the study at the time of recruitment. Written informed consent will be obtained and an Information sheet will be provided to all patients at the time of registration. 1st sitting of the Patha Nirgundi Ghrita suppository will be done. For Group A Patha Nirgundi Ghrita suppository will be done and for Group B Paracetamol suppository will be done. The suppository will be pushed into the anal verge till it enters into the sphincter. 2nd, 3rd, 4th and 5th sitting will be done continuously for 5 days and follow up after 7 days, |