| CTRI Number |
CTRI/2017/03/008229 [Registered on: 27/03/2017] Trial Registered Retrospectively |
| Last Modified On: |
23/03/2017 |
| 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 study the anaesthetic & pain releiving effect of Yashtimadhu Ghrita & Ghrita after haemorrhoidectomy pain |
|
Scientific Title of Study
|
A Comparative evaluation of anaesthetic & analgesic effect of Yashtimadhu ghrita & ghrita in the management of post haemorrhoidectomy pain. |
| Trial Acronym |
Yashtimadhu ghrita, Post haemorrhoidectomy pain |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Hirenkumar Balvantbhai Mistry |
| Designation |
MS shalya scholar |
| Affiliation |
Parul Institute of Ayurveda |
| Address |
Parul institute of Ayurveda, P.O. Limda, Ta. Waghodia, dist. Vadodara Pin.391760
Gujarat India
Vadodara
GUJARAT
391760
India |
| Phone |
9427637420 |
| Fax |
|
| Email |
drhirenmistry@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Hemant Toshikhane |
| Designation |
Professor |
| Affiliation |
Parul Institute Of Ayurveda |
| Address |
Parul institute of Ayurveda, P.O. Limda, Ta. Waghodia, Dist. Vadodara Pin.391760
Gujarat India
Vadodara
GUJARAT
391760
India |
| Phone |
9964596478 |
| Fax |
|
| Email |
drhemantt@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Hemant Toshikhane |
| Designation |
Professor |
| Affiliation |
Parul Institute Of Ayurveda |
| Address |
Parul institute of Ayurveda, P.O. Limda, Ta. Waghodia,
Dist. Vadodara Pin.391760
Gujarat India
Vadodara
GUJARAT
391760
India |
| Phone |
9964596478 |
| Fax |
|
| Email |
drhemantt@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Pharmacy
Parul institute of Ayurveda, P.O. Limda, Ta. Waghodia, Dist. Vadodara Pin.391760
Gujarat India |
|
|
Primary Sponsor
|
| Name |
Dr Hirenkumar B Mistry |
| Address |
Parul institute of Ayurveda, P.O. Limda, Ta. Waghodia, Dist. Vadodara Pin.391760
Gujarat India
GUJARAT INDIA |
| Type of Sponsor |
Other [Parul Institute Of Ayurveda Limda Vadodara] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Dr Hemant Toshikhane |
PARUL INSTITUTE OF AYURVEDA, P.O. LIMDA, TA. WAGHODIA. DIST. VADODARA PIN 391760 |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Hirenkumar Balvantbhai Mistry |
Parul Institute of Ayurveda hospital |
Room no 115-117
Department of Shalya tantra
Vadodara
GUJARAT |
9427637420
drhirenmistry@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| The Parul Institute of Ayurveda Institutional Ethics Committee on Human Research (PIA-IECHR) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Operated patients of haemorrhoidectomy complaining of Pain.
Age group - between 16-60 yrs, irrespective of sex, religion and socio-economic status., |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Plain ghrita |
20ml of plain ghrita will be applied intra rectally (Intra-anal) in the morning after meal for 15 days from the 1st post op day |
| Intervention |
Yashtimadhu ghrita |
20ml of Yashtimadhu ghrita will be applied intra rectally (Intra-anal) in the morning after meal for 15 days from the 1st post operative day |
|
|
Inclusion Criteria
|
| Age From |
16.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Operated patients of haemorrhoidectomy complaining of Pain.
Age group - between 16-60 yrs, irrespective of sex, religion and socio-economic status. |
|
| ExclusionCriteria |
| Details |
Age<16 yrs & age > 60 yrs.
Patients suffering from other systemic and metabolic diseases like Diabetes mellitus, tuberculosis, HIV, HbsAg, anaemia, chronic renal failure etc.
Patients not willing for local application intra rectally (Intra-anal) of Yashtimadhu Ghrita. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Assessment will be made with the following parameters:
Subjective parameters: Pain
The characteristic feature of pain will be documented and analyzed based on VAS.
Pain will be assessed by Intensity and duration-after defecation. |
Assessment of pain will be done after post operative anesthesia withrawal every 2 hrs upto 8hrs and before treatment & after treatment upto 7 days from 1st post operative day.
Follow up will be taken 0-7thday, 14th & 21st day.
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Criteria for Pain:
INTENSITY - VAS (VISUAL ANALOUGE SCALE)
S. No Parameter Criteria Grade
1. Intensity Of Pain No Pain 0
2. Mild Pain 1-3
3. Moderate Pain 4-6
4. Severe Pain 7-10
|
DURATION – AFTER DEFECATION
Sr. No Parameter Criteria Grade
Duration of pain
1. No pain 0
2. Pain, lasting for max. 10 min. 1
3. Pain, lasting for more than 10 min. upto 1 hr. 2
4. Pain, lasting for almost half a day 3
5. Pain, throughout the day 4
|
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
01/05/2015 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
None Yet
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Post opertive pain is Nociceptive; anticipated unavoidable physiological pain which is caused due to tissue trauma. Drugs such as NSAIDs and opioids are used for post operative management but are associated with their own drawbacks. Yashtimadhu ghrita has been in use in Ayurvedic practice for analgesia - shashtra nipatjanya vedana. It is known to relieve pain and can be used to supplement anaesthesia and also get rid of adverse effect of modern analgesic drugs.
There are very few Ayurvedic treatments available for post haemorrhoidectomy pain management. Therefore, this study is planned for establishing and to screen the effect of Yashtimadhu Ghrita as Ayurvedic treatment modality for post haemorrhoidectomy pain.
This study is randomised, intervantional, parallel group trail, comparing the anesthetic and analgesic effect of Yashtimadhu ghrita & plain ghrita;20ml intra-rectally for 15 days from 1st post operative day in 60 patient of post haemorrhoidectomy pain. The primary outcome will be measured by subjective parameters pain intensity wise analyzed on VAS The secondary outcome will be measured by pain duration after defecation analyzed on gradation mention as above format. |