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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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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.


 
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