| CTRI Number |
CTRI/2023/07/055787 [Registered on: 27/07/2023] Trial Registered Prospectively |
| Last Modified On: |
26/07/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A clinical trial to study the effects of two drugs, eranda suppository & diclofenac suppository in patients with post operative haemorrhoidectomy pain |
|
Scientific Title of Study
|
A comparative clinical trial to evaluate the efficacy of Eranda suppository & Diclofenac suppository in the management of post Haemorrhoidectomy pain. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Yogesh Kanna V |
| Designation |
PG Scholar |
| Affiliation |
S D M Institute of Ayurveda and Hospital |
| Address |
Department of shalya tantra,OPD NO:21
Anchepalya, Kumbalagodu post, Bengaluru
Department of shalya tantra,OPD NO:21
Anchepalya, Kumbalagodu post, Bengaluru
Bangalore
KARNATAKA
560074
India |
| Phone |
9080560098 |
| Fax |
|
| Email |
yogeshkannav@sdmayurbangalore.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Yogesh Kanna V |
| Designation |
PG Scholar |
| Affiliation |
S D M Institute of Ayurveda and Hospital |
| Address |
Department of shalya tantra,OPD NO:21
Anchepalya, Kumbalagodu post, Bengaluru
Department of shalya tantra,OPD NO:21
Anchepalya, Kumbalagodu post, Bengaluru
Bangalore
KARNATAKA
560074
India |
| Phone |
9080560098 |
| Fax |
|
| Email |
yogeshkannav@sdmayurbangalore.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Bharathi D Anvekar |
| Designation |
Professor |
| Affiliation |
S D M Institute of Ayurveda and Hospital |
| Address |
Department of shalya tantra,OPD NO:21
Anchepalya, Kumbalagodu post, Bengaluru
Department of shalya tantra,OPD NO:21
Anchepalya, Kumbalagodu post, Bengaluru
Bangalore
KARNATAKA
560074
India |
| Phone |
9886410690 |
| Fax |
|
| Email |
bharathisanjeev@sdmayurbangalore.in |
|
|
Source of Monetary or Material Support
|
|
SDM Institute of Ayurveda and Hospital, Anchepalya, Kumbalagodu post, Bengaluru-74
Department of Shalyatantra |
|
|
Primary Sponsor
|
| Name |
Dr Yogesh Kanna V |
| Address |
S D M Institute of Ayurveda and Hospital, Anchepalya, Kumbalagodu post, Bengaluru |
| 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 Yogesh Kanna V |
S D M Institute of Ayurveda & Hospital |
S D M Institute of Ayurveda and Hospital, Anchepalya, Kumbalagodu post, Bengaluru-74
Department of Shalya Tantra, OPD-20, Major OT
Bangalore
KARNATAKA |
9080560098
yogeshkannav@sdmayurbangalore.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committe Sri Dharmasthala Manjunatheswara institute of ayurveda and hospital bengaluru |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:K649||Unspecified hemorrhoids. Ayurveda Condition: ARSAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm (Non Ayurveda) | | - | | Medicine name:Diclofenac suppository, Dose:50mg, Route:Rectal, Dosage form:Suppository, Frequency:BD, Duration:4days, Additional information: On POD-0 only 1 suppository followed by BD dose for next 3 days | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: ERANDA , Reference: Dravyaguna Vijnana by Gyannendra Pandey, 4th ed, Route: Rectal, Dosage Form: Varti/ Suppository, Dose: 2(g), Frequency: bd, Bhaishajya Kal: Antarabhakta, Duration: 4 Days, anupAna/sahapAna: No, Additional Information: -On POD-0 only 1 suppository followed by BD dose for next 3 days |
|
|
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Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
- Subjects who have undergone Haemorrhoidectomy will be included irrespective of the gender, occupation and religion.
- Subjects from 20 to 60 years will be included to the study. |
|
| ExclusionCriteria |
| Details |
Subjects who have undergone Haemorrhoidectomy along with combined surgeries for fissure, fistula, infected case, abscess to be excluded. |
|
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Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
- Pain
|
Assessment will be done POD-0 POD-1 POD- 2 & POD-3(24th hourly).
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| -Tenderness |
Assessment will be done POD-0 POD-1 POD- 2 & POD-3(24th hourly).
|
|
|
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
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
10/08/2023 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
Pain is an unpleasant sensory and emotional experience associated with actual or
potential tissue damage or described in terms of such damage . Proper pain
management in postoperative period is essential as it is associated with stress and
systemic complication that include chiefly pulmonary, cardiovascular and gastro
intestinal system.The prevalence of Post-operative pain was 84.17 % in 5th post
Operative hour, 92.5% in 2nd post-operative day and 96.66% in 3rd post-operative
day.The incidence of moderate to severe pain following conventional
haemorrhoidectomy reported in the literature as high as 65% .Many patient are
reluctant to submit to haemorrhoidectomy because the operation has become notorious
of being associated with a great deal of Post operative pain .
Most commonly opioids and NSAIDS are used as analgesics in Post operative period.
Rectal suppositories are intended for localized or systemic action to relieve pain.
Diclofenac suppository is one of the widely used analgesic into rectum especially in
post haemorrhoidectomy. But it has limited effectiveness, safety and high risk factors
such as headache, hypertension, drowsiness, local rectal irritation, rectal bleeding,
black stool, persistent stomach pain and allergic reaction like rashes, itching and
swelling may develop .
Acharya Susrutha mentions there is no ruja without vata .Varti Kalpana is the
derivative of vati Kalpana. Guda varti is type of varti which is inserted to rectum. It
helps to expel the sanchita dosha .Eranda is having properties such as vatahara,
margasodhana and it is indicated in Shula and Shopha .Suppository is the modification
of Varti kalpana. So a Suppository is prepared out of Eranda which will be helpful in
Post-operative pain.
So current study is to evaluate the efficacy of Eranda suppository and Diclofenac
suppository in the post haemorrhoidectomy pain management. |