| CTRI Number |
CTRI/2024/04/065803 [Registered on: 16/04/2024] Trial Registered Prospectively |
| Last Modified On: |
14/12/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A clinical trial to evaluate the efficacy of Gudavarti of Trailokya Vijaya Vati, an Ayurvedic Suppository, for Post Operative Pain Management Inguinal Hernia. |
|
Scientific Title of Study
|
A Randomized Controlled Clinical Trial to Evaluate the Comparative Efficacy of Gudavarti of Trailokya Vijaya Vati with Diclofenac Sodium Suppository for Post-Operative Pain Management in Antra Vriddhi W.S.R. to Inguinal Hernia |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Prof Anil Dutt |
| Designation |
Professor and Head |
| Affiliation |
Rajiv Gandhi Government Post Graduate Ayurvedic College and Hospital Paprola |
| Address |
Room No. 207
PG Department of Shalya Tantra
Anatomy Block
RGGPGACH Paprola
Tehsil Baijnath
DIistrict Kangra HP
Kangra
HIMACHAL PRADESH
176115
India |
| Phone |
8351005225 |
| Fax |
01894242064 |
| Email |
dr_seemanil@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof Anil Dutt |
| Designation |
Professor and Head |
| Affiliation |
Rajiv Gandhi Government Post Graduate Ayurvedic College and Hospital Paprola |
| Address |
Room No. 207
PG Department of Shalya Tantra
Anatomy Block
RGGPGACH Paprola
Tehsil Baijnath
DIistrict Kangra HP
Kangra
HIMACHAL PRADESH
176115
India |
| Phone |
8351005225 |
| Fax |
01894242064 |
| Email |
dr_seemanil@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr ASHISH AWASTHI |
| Designation |
PG Scholar |
| Affiliation |
Rajiv Gandhi Government Post Graduate Ayurvedic College and Hospital Paprola District Kangra HP |
| Address |
Room No. 321
PG Department of Shalya Tantra
RGGPGACH Paprola
Tehsil Baijnath
DIistrict Kangra HP
Kangra
HIMACHAL PRADESH
176115
India |
| Phone |
9805330593 |
| Fax |
01894242064 |
| Email |
dr.aashishawasthi@gmail.com |
|
|
Source of Monetary or Material Support
|
| Baijnath Pharmacy Paprola District kangra Himachal Pradesh 176115
Government Charak Pharmacy
Rajiv Gandhi Government Post Graduate Ayurvedic College and Hospital Paprola District Kangra HP 176115
Regional Institution ISM Jogindar Nagar District Mandi HP |
|
|
Primary Sponsor
|
| Name |
Rajiv Gandhi Government Post Graduate Ayurvedic College and Hospital Paprola |
| Address |
Rajiv Gandhi Government Post Graduate Ayurvedic College and Hospital Paprola
Tehsil Baijnath
DIistrict Kangra HP |
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Prof ANIL DUTT |
Room No. 207
PG Department of Shalya Tantra
Anatomy Block
RGGPGACH Paprola
Tehsil Baijnath
DIistrict Kangra HP 176115 |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Prof Dr Anil Dutt |
Rajiv Gandhi Government Post Graduate Ayurvedic College and Hospital Paprola |
Room No. 105
Department of Shalya Tantra
Rajiv Gandhi Government Post Graduate Ayurvedic College and Hospital Paprola
Tehsil Baijnath
District Kangra
Himachal Pradesh 176115
Kangra
HIMACHAL PRADESH |
8351005225
01894242064
dr_seemanil@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee (Human) Rajiv Gandhi Government Post Graduate Ayurvedic College and Hospital Paprola District Kangra Himachal Pradesh 176115 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:K409||Unilateral inguinal hernia, without obstruction or gangrene. Ayurveda Condition: ANTRA-VRUDDHIH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Trailokya vijaya vati, Reference: Ayurved Sar Sangrah Page No. 515, Route: Rectal, Dosage Form: Varti/ Suppository, Dose: 125(mg), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 1 Days, anupAna/sahapAna: No, Additional Information: Gudavarti of Trailokya vijaya vati will be given after operative procedure and withdrawal of anaesthetic effect of spinal/ general anaesthesia | | 2 | Comparator Arm (Non Ayurveda) | | - | Diclofenac sodium suppository | Diclofenac Sodium Suppository will be given after operative procedure and withdrawal of anaesthetic effect of spinal/ general anaesthesia.
Route: rectal
Dosage form: suppository
Dose: 100mg
Frequency: 12 hourly
Duration: 24 hours |
|
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
Patients undergone surgery for Inguinal Hernia (Direct, Indirect, Complete, Incomplete) under Spinal Anesthesia/ General Anesthesia
Patients who have given informed and written consent to participate in the trial.
Age - 20 to 75 years, of either gender.
ASA I & II physical status.
|
|
| ExclusionCriteria |
| Details |
Patients of Inflamed / Strangulated/ Obstructed/ Recurrent Inguinal Hernia
Patients not falling under the ASA grade-I & II
Patients allergic to Trailokya Vijaya Vati or its contents, Diclofenac sodium or other NSAIDs
Patients with H/O Drug Addiction, Drug Addicts
Patients with bowel incontinence, diarrhea, ano-rectal disorders esp. fissure-in-ano, haemorrhoids or active ano-rectal bleeding.
Pregnant / Breast feeding women.
Any other condition, which the Principal Investigator thinks may jeopardize the study.
|
|
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Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. To compare the effect of Gudavarti of Trailokya Vijaya Vati with established known analgesic suppository of Diclofenac, in Post-operative pain management of Inguinal Hernia.
2. To substantiate the analgesic action of Trailokya Vijaya Vati for post-operative pain management, as a rectal analgesic drug (Gudavarti).
3. To determine onset of analgesic action of Gudavarti of Trailokya Vijaya Vati based on subjective criteria.
4. To compare the extent of pain relief after the use of Gudavarti of Trailokya Vijaya Vati with that of Suppository of Diclofenac Sodium at the end of 24 hours study period. |
Pain assessment will be conducted at the baseline, prior to the administration of the first dose. Subsequently, pain levels will be recorded at 30-minute interval, and at 1.5-hour, 3-hour, 6-hour, 12- hour, and 24- hour based on subjective parameters for a total of 24 hours. Pain recordings will be conducted prior to the administration of the subsequent dose. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. To explore the literature, regarding pain and its management through rectal route.
2. To explore the literature, regarding Inguinal Hernia and its surgical management.
3. To study the adverse effects of Gudavarti of Trailokya Vijaya Vati and suppository of Diclofenac Sodium
|
The trial patients will be monitored for any adverse effects during their inpatient stay or at the one-week follow-up.
|
|
|
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)
|
25/04/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
25/04/2024 |
| 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)
Modification(s)
|
Open to Recruitment |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
Primary Objective of the study is to 1. To compare the effect of Gudavarti of Trailokya Vijaya Vati with established known analgesic suppository of Diclofenac, in Post-operative pain management of Inguinal Hernia. 2. To substantiate the analgesic action of Trailokya Vijaya Vati for post-operative pain management, as a rectal analgesic drug (Gudavarti). 3. To determine onset of analgesic action of Gudavarti of Trailokya Vijaya Vati based on subjective criteria. 4. To compare the extent of pain relief after the use of Gudavarti of Trailokya Vijaya Vati with that of Suppository of Diclofenac Sodium at the end of 24 hours study period. 30 patients will be randomly selected in 2 groups of 15 patients each. One suppository of Diclofenac Sodium in the dose of 100 mg, 12 hourly, through rectal route, as Control Drug in Group I
One Gudavarti of Trailokya Vijaya Vati in the dose of 125 mg, 12 hourly, through rectal route as Trial Drug in Group II
Method of administration of the studied drugs
Rectal route as Gudavarti / suppository.
After the operative procedure and withdrawal of anesthetic effect of spinal/ general anesthesia suppository of Diclofenac sodium and Gudavarti of Trailokya vijaya vati will be administered in left lateral position, in the patients of Control group and Trial group respectively.
The clinical evaluation in this study will involve assessing the drug’s analgesic properties at 30 minutes, 1.5 hour, 3 hours, 6 hours, 12 hours, and 24 hours based on subjective parameters. The trial patients will be monitored for any adverse effects during their inpatient stay or at the one-week follow-up.
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