| CTRI Number |
CTRI/2019/06/019885 [Registered on: 26/06/2019] Trial Registered Prospectively |
| Last Modified On: |
25/06/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
TO EVALUATE THE EFFICACY OF SHIGRU-NIRGUNDI GHAN VATI IN POSTOPERATIVE PAIN MANAGEMENT |
|
Scientific Title of Study
|
A COMPARATIVE STUDY TO EVALUATE THE EFFICACY OF SHIGRU-NIRGUNDI GHAN VATI IN POSTOPERATIVE PAIN W.S.R. TO ANAL FISSURE |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
SHRADDHA SAHU |
| Designation |
M.S. SCHOLAR |
| Affiliation |
NATIONAL INSTITUTE OF AYURVEDA JAIPUR RAJASTHAN |
| Address |
NATIONAL INSTITUTE OF AYURVEDA JAIPUR RAJASTHAN
AMER ROAD MADHAV VILAS JAIPUR
302002
shalya tantra department
opd no- 28
national institute of ayurveda jaipur.
Jaipur
RAJASTHAN
302002
India |
| Phone |
8839929943 |
| Fax |
|
| Email |
shraddhasahu21791@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR ASHOK KUMAR |
| Designation |
ASSOCIATE PROFESSOR |
| Affiliation |
NATIONAL INSTITUTE OF AYURVEDA JAIPPUR,RAJASTHAN |
| Address |
NATIONAL INSTITUTE OF AYURVEDA JAIPUR RAJASTHAN
AMER ROAD MADHAV VILAS JAIPUR
shalya tantra department
opd no- 28
national institute of ayurveda jaipur.
Jaipur
RAJASTHAN
302002
India |
| Phone |
9649180572 |
| Fax |
|
| Email |
ashok_hp1976@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
DR ASHOK KUMAR |
| Designation |
ASSOCIATE PROFESSOR |
| Affiliation |
NATIONAL INSTITUTE OF AYURVEDA JAIPPUR,RAJASTHAN |
| Address |
NATIONAL INSTITUTE OF AYURVEDA JAIPUR RAJASTHAN
AMER ROAD MADHAV VILAS JAIPUR
shalya tantra department
opd no- 28
national institute of ayurveda jaipur.
Jaipur
RAJASTHAN
302002
India |
| Phone |
9649180572 |
| Fax |
|
| Email |
ashok_hp1976@yahoo.com |
|
|
Source of Monetary or Material Support
|
| NATIONAL INSTITUTE OF AYURVEDA PHARMACY JAIPUR RAJASTHAN MADHAV VILAS JAIPUR
302002 |
|
|
Primary Sponsor
|
| Name |
NATIONAL INSTITUTE OF AYURVEDA JAIPUR RAJASTHAN |
| Address |
NATIONAL INSTITUTE OF AYURVEDA JAIPUR RAJASTHAN
AMER ROAD MADHAV VILAS JAIPUR |
| Type of Sponsor |
Government 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 |
| SHRADDHA SAHU |
NATIONAL INSTITUTE OF AYURVEDA HOSPITAL JAIPUR RAJASTHAN |
SHALYA TANTRA DEPARTMENT
OPD NO-28
Jaipur
RAJASTHAN |
8839929943
shraddhasahu21791@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE NATIONAL INSTITUTE OF AYURVEDA |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K626||Ulcer of anus and rectum, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
SHIGRU - NIRGUNDI GHAN VATI |
Group II –
SHIGRU - NIRGUNDI GHAN VATI – 500 mg 8 hourly with water.
Group III – SHIGRU - NIRGUNDI GHAN VATI – 1 gm 8 hourly with water. |
| Comparator Agent |
SHIGRU - NIRGUNDI GHAN VATI
DICLOFENAC SODIUM 50MG |
DOSE-
Group I – Diclofenac Sodium – 50 mg with water
Group II – SHIGRU - NIRGUNDI GHAN VATI – 500 mg with water
Group III – SHIGRU - NIRGUNDI GHAN VATI – 1 gm with water.
FREQUENCY- TDS(Thrice a day)
Route- orally
|
|
|
Inclusion Criteria
|
| Age From |
16.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients undergoing surgical intervention for Parikartika (Anal Fissure) of age between 16 – 60 years irrespective of gender, religion etc.
2. Patients not requiring to be kept nil via mouth in postoperative period.
3. Willing to participate in the study.
|
|
| ExclusionCriteria |
| Details |
1. Patient not willing to participate in the trial.
2. Patient below age of 16 and more than 60yrs.
3. Please specify –antihypertensive,lipid lower medicines,thyroid disorders.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Pre-numbered or coded identical Containers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| TO GET RELIEVE ON POSTOPERATIVE PAIN |
3 DAYS |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| PAIN RELIEF. |
3 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 3/ Phase 4 |
|
Date of First Enrollment (India)
|
01/09/2019 |
| 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="0"
Months="0"
Days="3" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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)?
|
|
Brief Summary
|
Pain
is the most important symptom in clinical practice which compels an individual
to seek medical advice. When someone undergoes any surgical intervention
whether minor or major, first thing which comes in the mind of that individual is
that it will involve pain after the procedure, which is very true. There is
little doubt that surgical intervention whether minor or major will involve
some sort of pain, intensity of which may vary from minor discomfort to severe
pain. Pain can be classified variously viz. acute and chronic, mild moderate or
severe. Patients undergoing surgical procedures suffer postoperative pain which
is obvious. Postoperative pain management is an important part in surgical
practice which is often underestimated. Data suggest that 80% of patients
experience postoperative pain1. 11 to 20 percent of patients
experience severe pain postoperatively2. |