| CTRI Number |
CTRI/2024/11/076411 [Registered on: 08/11/2024] Trial Registered Prospectively |
| Last Modified On: |
24/10/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Surgical/Anesthesia
Preventive |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Management of post operative Pain of pile surgery With Dashanga Ghrita. |
|
Scientific Title of Study
|
A Randomised Controlled Clinical Trial To Evaluate Analgesic Effect Of Dashanga Ghrita In The Management Of Post Haemorrhoidectomy Pain. |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Sachin Dineshbhai Kar |
| Designation |
PG Scholar |
| Affiliation |
G.J. Patel Institute Of Ayurvedic Studies And Research. |
| Address |
Department of Shalya Tantra, OPD No. 25, S. G. Patel Ayurveda Hospital and Maternity Home, New Vallabh Vidyanagar, Anand, Gujarat - 388120
Anand
GUJARAT
388120
India |
| Phone |
7433850185 |
| Fax |
|
| Email |
karsachind@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Dipsinh B Chavda |
| Designation |
HOD And Professor |
| Affiliation |
G.J. Patel Institute Of Ayurvedic Studies And Research. |
| Address |
Department of Shalya Tantra, OPD No. 25, S. G. Patel Ayurveda Hospital and Maternity Home, New Vallabh Vidyanagar, Anand, Gujarat - 388120
Anand
GUJARAT
388120
India |
| Phone |
9428491219 |
| Fax |
|
| Email |
dispinh.chavda@cvmu.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Dipsinh B Chavda |
| Designation |
HOD And Professor |
| Affiliation |
G.J. Patel Institute Of Ayurvedic Studies And Research. |
| Address |
Department of Shalya Tantra, OPD No. 25, S. G. Patel Ayurveda Hospital and Maternity Home, New Vallabh Vidyanagar, Anand, Gujarat - 388120
Anand
GUJARAT
388120
India |
| Phone |
9428491219 |
| Fax |
|
| Email |
dispinh.chavda@cvmu.edu.in |
|
|
Source of Monetary or Material Support
|
| S.G Patel Ayurveda Hospital and
Maternity home |
|
|
Primary Sponsor
|
| Name |
Dr Sachin Dineshbhai Kar |
| Address |
G.J. Patel Institute Of Ayurvedic Studies And Research & S.G. Patel Ayurveda Hospital & Maternity Home, New Vallabh Vidya Nagar, Anand, Gujarat-388120. |
| 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 Sachin Dineshbhai Kar |
S. G. Patel Ayurveda Hospital And Maternity Home |
OPD No. 25, Dept. of Shalya Tantra, New Vallabh Vidya Nagar, Anand, Gujarat-388120
Anand
GUJARAT |
7433850185
karsachind@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| G. J. Patel Institute of Ayurvedic Studies and Research, S. G. Patel Ayurveda Hospital & Maternity Home |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:K918||Other intraoperative and postprocedural complications and disorders of digestive system. Ayurveda Condition: ARSA-UPADRAVAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Dashang Ghrita, Reference: Sahashra Yogam Ghrita Kalpana Adhyay, Route: Rectal, Dosage Form: Ghrita, Dose: 20(ml), Frequency: od, Bhaishajya Kal: Pragbhakta, Duration: 7 Days, anupAna/sahapAna: No, Additional Information: - | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Go Ghrita, Reference: Sushruta samhita Chikistasthan 1, Route: Rectal, Dosage Form: Ghrita, Dose: 20(ml), Frequency: od, Bhaishajya Kal: Pragbhakta, Duration: 7 Days, anupAna/sahapAna: No, Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1) Operated participants of haemorrhoidectomy after initiation of Pain / after 24 hours of surgery if
rescue drug administered.
2) Age group between 18 to 60 yrs., irrespective of gender, religion and socioeconomic status.
|
|
| ExclusionCriteria |
| Details |
1) Participants suffering from other systemic and metabolic diseases like Diabetes mellitus, tuberculosis,
HIV, HbsAg, anaemia, chronic renal failure etc.
2) Pregnant Lady & Lactating mother.
3) Participants not willing for intra rectal application of the drug.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Open Label |
|
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 |
| impact on complete pain subsided |
every 7th day |
|
|
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 3/ Phase 4 |
|
Date of First Enrollment (India)
|
10/11/2024 |
| 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 Applicable |
| 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
|
Postoperative 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 drawbacks. Dashanga ghrita has been used in Ayurvedic practice for analgesia -as per Sahasra yogam reference. It is known to relieve pain and can be used to supplement analgesia and also get rid of adverse effects of modern analgesic drugs. There are very few Ayurvedic treatments available for post-haemorrhoidectomy pain management. Therefore, this study is planned to establish and to screen the effect of Dashanga Ghrita as an Ayurvedic treatment modality for post-haemorrhoidectomy pain. This study is a randomized, interventional, parallel-group trial, comparing the analgesic effect of Dashanga Ghrita & plain ghrita;20ml intra-rectally for 07 days from 1st post-operative day in 30 patients 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 the abovementioned gradation format. |