| CTRI Number |
CTRI/2019/08/020955 [Registered on: 28/08/2019] Trial Registered Prospectively |
| Last Modified On: |
27/08/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Effect of Yashtimadhu suppository as pain killer in post operative ano rectal pain |
|
Scientific Title of Study
|
A clinical study of analgesic effect of Yashtimadhu suppository in the management of post operative pain ano rectal pain |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Jayanta Malakar |
| Designation |
PG scholar |
| Affiliation |
parul institute of ayurved |
| Address |
department of shalya tantra, parul institute of ayurved, parul university, p.o. limda, waghodia, vadodara p.11 sivan koil 2ndd street kumaran nagar Vadodara GUJARAT 391760 India |
| Phone |
09444862281 |
| Fax |
|
| Email |
drjmalakar@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr S L pandya |
| Designation |
professsor |
| Affiliation |
parul institute of ayurved |
| Address |
department of shalya tantra, parul institute of ayurved, parul university, p.o. limda, waghodia, vadodara
Vadodara GUJARAT 391760 India |
| Phone |
9427899033 |
| Fax |
|
| Email |
sureshpandya912@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr S L pandya |
| Designation |
professsor |
| Affiliation |
parul institute of ayurved |
| Address |
department of shalya tantra, parul institute of ayurved, parul university, p.o. limda, waghodia, vadodara
Vadodara GUJARAT 391760 India |
| Phone |
9427899033 |
| Fax |
|
| Email |
sureshpandya912@gmail.com |
|
|
Source of Monetary or Material Support
|
| Parul ayurved hospital
Opd no. 116, parul ayurved hospital, parul university, limda, vadodara - 391760 |
|
|
Primary Sponsor
|
| Name |
Parul Institute of Ayurved |
| Address |
parul institute of ayurved, parul university, p.o. limda, waghodia, vadodara |
| Type of Sponsor |
Private medical college |
|
|
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 Jayanta Malakar |
Parul ayurved hospital |
OPD no. 116, Department of shalya tantra, parul university, limda, vadodara Gujarat Vadodara GUJARAT |
9444862281
drjmalakr@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| PIA - IECHR |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: T888||Other specified complications of surgical and medical care, not elsewhere classified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NOT APPLICABLE |
NOT APPLICABLE |
| Intervention |
yashtimadhu suppositories |
yashtimadhu anal suppositories
contains yashtimadhu extract and coco butter is used as base. dose 1 suppositories will be given per rectum every 12 hrs for 7 days |
|
|
Inclusion Criteria
|
| Age From |
15.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients irrespective of the Sex & Occupation for the study of Patients who have underwent anorectal surgery.
2. Patient’s age group above 15 years.
|
|
| ExclusionCriteria |
| Details |
1. Patient with any systemic diseases.
2. Patient with infective wound.
3. Patient with malignant conditions
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| relief from post operative anorectal pain. |
7 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| no relief from post operative pain. |
7 days |
|
|
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)
|
06/09/2019 |
| 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
|
not yet done |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Hypothesis : yashtimadhu suppositories are effective in post operavtive ano rectal pain.
Pain is the most common symptom that brings patients to see a physician and it is the basic and most challenging problem for surgeons
from primitive era and is the very common post-operative manifestation after any surgical procedure, no matter how good operation is performed. Excessive pain will be unbearable and will lead to other effects like nausea, palpitation and increase or decrease
of blood pressure. When post-operative pain is inadequately treated the suffering
of the patient increases
the stress of the whole procedure and can delay recovery.
Hence management of postoperative pain has been a global challenge since the inception
of surgery with opiates especially, there are exaggerated fears regarding their potential for side effects
and their addictions. In present modern
era also a well-established NSAID, Diclofenac sodium
has various side effects like nausea/vomiting, ulceration, GI bleeding and adverse renal effectsi.
Acharya Sushruta has explained specifically in Sutrastana about the management of pain in post-operative condition. He has mentioned
that in the pain which is caused
post- surgery, can be manage by the application of yashtimadhu and luke warm ghrita and this formulation has been proved
to be effective. The lack of effective
analgesics in Ayurvedic
medicines is the main disadvantage for the down fall of Ayurvedic surgery, so there is constant quest for an ideal Ayurvedic analgesic therapy. There is immense amount of pain in the post-operative conditions, due to which patients are afraid to undergo surgery.
So, in order to overcome
this problem and to create a new treatment
modality in Ayurveda for pain management an attempt is made by preparing suppositories using Yastimadhu, which is easily available, cost effective and easy to prepare. Keeping this in mind, an attempt
is made to prepare suppositories of yashtimadhu and analyse its effectiveness in ano rectal
post-operative pain.
|