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CTRI Number  CTRI/2024/06/069133 [Registered on: 18/06/2024] Trial Registered Prospectively
Last Modified On: 11/06/2024
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   Management of Inguinal Hernia with and without Erandatailapana 
Scientific Title of Study   A Clinico Comparative Study of Desarda Hernia Repair with and without Erandatailapana as a Purvakarma in the Management of Apraptphalakosha Antravriddhi (Inguinal Hernia)-An Open Label Randomized Comparative Clinical Trial 
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 Komal Jitendrabhai Kapadiya 
Designation  PG Scholar 
Affiliation  Government Akhandanand Ayurveda College And Hospital 
Address  OPD No 24 Shalyatantra Department Government Akhandanand Ayurveda College and Hospital Bhadra Ahmedabad 380001

Ahmadabad
GUJARAT
380001
India 
Phone  7046970763  
Fax    
Email  kapadiyakomal2017@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Rajesh Kumar Sharma 
Designation  Professor and HOD  
Affiliation  Government Akhandanand Ayurveda College And Hospital 
Address  OPD No 24 Shalyatantra Department Government Akhandanand Ayurveda College and Hospital Bhadra Ahmedabad 380001

Ahmadabad
GUJARAT
380001
India 
Phone  9408205584  
Fax    
Email  dr.rajeshsharma38@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Rajesh Kumar Sharma 
Designation  Professor and HOD  
Affiliation  Government Akhandanand Ayurveda College And Hospital 
Address  OPD No 24 Shalyatantra Department Government Akhandanand Ayurveda College and Hospital Bhadra Ahmedabad 380001

Ahmadabad
GUJARAT
380001
India 
Phone  9408205584  
Fax    
Email  dr.rajeshsharma38@gmail.com  
 
Source of Monetary or Material Support  
Government Akhandanand Ayurved College And Hospital Ahmedabad Gujarat 380001 India 
 
Primary Sponsor  
Name  Government Akhandanand Ayurveda College And Hospital 
Address  OPD No 24 Shalyatantra Department Government Akhandanand Ayurved College and Hospital Bhadra Ahmedabad 380001 
Type of Sponsor  Government medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Komal Kapadiya  Government Akhandanand Ayurveda College And Hospital  OPD No 24 Shalyatantra Department Government Akhandanand Ayurved College and Hospital Bhadra Ahmedabad 380001
Ahmadabad
GUJARAT 
7046970763

kapadiyakomal2017@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICAL COMMITTEE  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
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  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Comparator Arm (Non Ayurveda)-Desarda Hernia Repair Mesh less hernia repair
2Intervention ArmProcedure-virecana-karma, विरेचन-कर्म (Procedure Reference: Sushrut samhita chikitsasthana 19/06, Procedure details: Erandatailapana 20-40 ml. At night for 7 days and on the 8th day Desarda Hernia Repair will be done )
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  1 Patient with age of 18 to 70 years
2 Indirect inguinal hernia
3 Direct inguinal hernia
4 Unilateral /bilateral inguinal hernia
5 Controlled cases of hypertension and
diabetes mellitus
6 Diagnostic criterea will be included 
 
ExclusionCriteria 
Details  1 Scrotal Hernias
2 Strangulated Hernia
3 Congenital Hernia
4 If finger can get above swelling- scrotal swelling
5 HIV, HBsAG infected
6 Patients having Chronic Cough
7 Collegen and Connective tissue disorder
8 Melignancy Of Bowel, Colon And Testis 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
result will be assessed on the basis of relief in
assessment criteria
Pain,Swelling,Finger Invagination Test,Three
Finger Test (Zieman’s Technique) 
7 days  
 
Secondary Outcome  
Outcome  TimePoints 
Comparing the effect of both the procedure with
assessment criteria
Pain,Swelling,Finger Invagination Test,Three
Finger Test (Zieman’s Technique) 
2 MONTHS 
 
Target Sample Size   Total Sample Size="14"
Sample Size from India="14" 
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)   22/06/2024 
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="10"
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   A CLINOCO COMPARATIVE STUDY OF DESARDA HERNIA REPAIR WITH AND WITHOUT ERANDATAILAPANA AS A PURVAKARMA IN THE MANAGEMENT OF APRAPTPHALAKOSHA ANTRAVRIDDHI (INGUINAL HERNIA)- AN OPEN LABEL RANDOMIZED CPMPARATIVE CLINICAL TRIAL

Introduction

Hernia is derived from the Latin word for rupture. A hernia is defined as an abnormal protrusion of an organ or tissue through a defect in its surrounding walls. Although a hernia can occur at various sites of the body, these defects most commonly involve the abdominal wall, particularly the inguinal region. Abdominal wall hernias occur only at sites at which the aponeurosis and fascia are not covered by striated muscle.
An indirect inguinal hernia travels down the canal on the outer (lateral and anterior) side of the spermatic cord. A direct inguinal hernia comes out directly forwards through the posterior wall of the inguinal canal.
Indirect inguinal hernia this is the most common form of hernia. Indirect hernias are most common in the young one, whereas direct hernias are most common in the old
one. In the first decade of life, inguinal hernia is more common on the right side in the male. This is no doubt associated with the later descent of the right testis and a higher incidence of failure of closure of the processus vaginalis. In adult males, 65% of inguinal hernias are indirect and 55% are right-sided. The hernia is bilateral in 12% of cases.


Randomization will be done with the help of computer-generated Data. All the Patients will be selected from OPD and IPD of Government
Akhandanand Ayurvedic Hospital, bhadra and Smt. Maniben Ayurved
Hospital; Asarva, Ahmedabad. Patients will be selected irrespective of
caste, religion and occupation.



sample size 

14 Patients will be selected as per inclusion criteria and randomly divided in 2 groups and each group has same number of patient.


Group A - Desarda Hernia Repair.
Group B - Erandataila and Milk for 7 days. And on 8th day Desarda Hernia Repair will be done.



Diagnostic criteria

Lump in Inguinal swelling
Pain Characterized as a vague, dull and dragging worsening
by straining, lifting heavy weights.
Paresthesia in the inguinal canal
Location Above inguinal Ligament
Palpation - Location of impulse on cough found above
inguinal Ligament and Medial to Pubic Tubercle
Ring occlusion Test
Three Finger Test ( Zieman Technique )
Finger Invagination Test
USG Inguinoscrotal




 Pathyapathya 

 Keep the dressing and area around it clean and free from dirt or sweat.
Rest for several days after surgery.
Avoid any movement that might stretch or injure the stitches.
Avoid hitting or bumping the area.
Do not let the dressing get wet.
Do not touch the dressing.
Avoid strenuous exercise for several days.
The site may become itchy as it heals. Do not scratch the wound or  prick at it.
Do not rub or scrub the wound.
Inform immediately if increased drainage from the wound, drainage
becoming thick, green or yellow or smells bad (pus), feels fever.

 
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