| CTRI Number |
CTRI/2021/07/035231 [Registered on: 28/07/2021] Trial Registered Prospectively |
| Last Modified On: |
21/07/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Efficacy of Sirisha caplet with Diclofenac suppository in the management of post-operative pain. |
|
Scientific Title of Study
|
Randomized comparative clinical study to evaluate efficacy of Sirisha caplet with Diclofenac suppository in the management of post-operative pain in lower abdomen surgeries. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Bramhanand Subhash Chauhan |
| Designation |
PG scholar |
| Affiliation |
Sumatibhai shah ayurveda mahavidyalava |
| Address |
IPD ward no.2 Sane Guruji Hospital Malwadi Near Gadital Hadapsar Pune
IPD ward no.2 Sane Guruji Hospital Malwadi Near Gadital Hadapsar Pune
Pune
MAHARASHTRA
411028
India |
| Phone |
9284645635 |
| Fax |
|
| Email |
bramhanandc8@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DrRashmi Anil Kale |
| Designation |
MD Shalya PhD |
| Affiliation |
Sumatibhai shah ayurveda mahavidyalava |
| Address |
IPD ward no.2 Sane Guruji Hospital Malwadi Near Gadital Hadapsar Pune
IPD ward no.2 Sane Guruji Hospital Malwadi Near Gadital Hadapsar Pune
Pune
MAHARASHTRA
411028
India |
| Phone |
9822244893 |
| Fax |
|
| Email |
drrakale@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Bramhanand Subhash Chauhan |
| Designation |
PG Scholar |
| Affiliation |
Sumatibhai shah ayurveda mahavidyalava |
| Address |
IPD ward no.2 Sane Guruji Hospital Malwadi Near Gadital Hadapsar Pune
IPD ward no.2 Sane Guruji Hospital Malwadi Near Gadital Hadapsar Pune
Pune
MAHARASHTRA
411028
India |
| Phone |
9284645635 |
| Fax |
|
| Email |
bramhanandc8@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sane Guruji Hospital IPD OPD no3 Shalyatantra Department Hadapsar Pune. |
|
|
Primary Sponsor
|
| Name |
Dr Bramhanand Subhash Chauhan |
| Address |
Shalyatantra Department Malwadi Hadapsar Pune 415028 |
| 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 Bramhanand Subhash Chauhan |
Sane Guruji Hospital |
IPD ward no.2 Shalyatantra Department Sane Guruji Hospital Malwadi Hadapsar Pune 411028
Pune
MAHARASHTRA |
9284645635
bramhanandc8@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICAL COMMITTEE SSAM HADAPSAR PUNE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:R298||Other symptoms and signs involvingthe nervous and musculoskeletal systems. Ayurveda Condition: SULAH, (2) ICD-10 Condition:R298||Other symptoms and signs involvingthe nervous and musculoskeletal systems. Ayurveda Condition: SULAH, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Diclofenac suppository kept per rectally in post operative pain. |
To evaluate the efficacy of sirisha caplet in post operative pain management. sample size 30 patients are randomaly taken for this study. Total duration of study is 03 days. frequency of Diclofenac suppository 100mg will be kept per rectally as per pain VAS scale. |
| Intervention |
Sirisha caplet kept per rectally for post operative pain management. |
To evaluate the efficacy of sirisha caplet 1gram in post operative pain management. sample size 30 patients are randomaly taken for this study. Total duration of study is 03 days. frequency Sirisha caplet will be kept per rectally as per pain VAS scale. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
60 Patients will be taken in age group of 18-50 irrespective of gender.
Post operative patient who have been operated for lower abdomen surgeries includes ilio-inguinal surgeries, Ano-rectal surgeries, pelvic floor surgeries and surgeries related to genital region.
|
|
| ExclusionCriteria |
| Details |
Patients who suffers from diarrhoea,
Acute fissure,
Active P/R Bleeding.
CA rectum,
Tuberculosis of abdomen,
Dysentery.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Sirisha caplet is effective in post-operative pain management as a rectal analgesic. Pain assessment done by VAS scale. |
03 Days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Sirisha caplet is less/equal/more effective than Diclofenac suppository in post-operative pain management. Pain assessment done as per VAS scale. |
03 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 2 |
|
Date of First Enrollment (India)
|
01/08/2021 |
| 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
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
|
Randomized controlled clinical study
to evaluate efficacy of Sirisha caplet
with Diclofenac suppository in the management of post-operative pain.
|
There are Paracetamol and Diclofenac
suppository are available and working moderately. These drugs are having
adverse effect like rectal bleeding, rectal ulceration etc. An ultimate goal of surgical treatment
is approaching better recovery for a high quality of life without
complications and squeals. In NBM Patients rectal administration of
drugs having advantages. The
rectal route may represent a practical alternative and rectal administration
is now well accepted for delivering, for example, anticonvulsants, non-narcotic
and narcotic analgesics, theophylline, antiemetics and antibacterial agents,
and for inducing anaesthesia
Some medications can be inserted into anus
(rectal) as a suppository. They may contain active ingredients that have a
local effect. Rectal administration provides rapid absorption of many drug
and easy alternative to Intramuscular/Intravenous route. It is a
painless procedure the most important consideration are slow onset of
disintegration (minutes) absorption of medicine and the prolonged duration of
effect (analgesic) in rectal route. This study plan to access efficacy of sirisha caplet in the management of post operative pain. sample size 60 Duration 03 Days Administration sirisha caplet 1gram per rectally
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