| CTRI Number |
CTRI/2026/01/100628 [Registered on: 09/01/2026] Trial Registered Prospectively |
| Last Modified On: |
08/01/2026 |
| 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
|
To test the efficiency of Yashtimadhu Ghrita in post surgery wound of open inguinal hernia repair |
|
Scientific Title of Study
|
RANDOMIZED CONTROLLED TRIAL TO TEST THE EFFICACY OF YASHTIMADHU GHRITA IN THE POST SURGICAL OUTCOMES OF OPEN INGUINAL HERNIA REPAIR |
| 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 Danish |
| Designation |
MS Scholar |
| Affiliation |
National Institute of Ayurveda |
| Address |
Department of Shalya Tantra, National Institute of Ayurveda, Madhav Vilas Palace, Amer Road , Jaipur
Jaipur
RAJASTHAN
302002
India |
| Phone |
9756556388 |
| Fax |
|
| Email |
qdanish513@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Narinder Singh |
| Designation |
Professor |
| Affiliation |
National Institute of Ayurveda |
| Address |
Department of Shalya Tantra, National Institute of Ayurveda, Madhav Vilas Palace, Amer Road , Jaipur
Jaipur
RAJASTHAN
302002
India |
| Phone |
9549370912 |
| Fax |
|
| Email |
narinder.1973@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Danish |
| Designation |
MS Scholar |
| Affiliation |
National Institute of Ayurveda |
| Address |
Department of Shalya Tantra, National Institute of Ayurveda, Madhav Vilas Palace, Amer Road , Jaipur
Jaipur
RAJASTHAN
302002
India |
| Phone |
9756556388 |
| Fax |
|
| Email |
qdanish513@gmail.com |
|
|
Source of Monetary or Material Support
|
| National Institute of Ayurveda Near Jorawar Singh gate Jaipur Pin code 302002 Rajasthan India.
|
|
|
Primary Sponsor
|
| Name |
National Institute of Ayurveda |
| Address |
Madhav Villas, Amer Road,Jaipur, Rajasthan 302002 |
| Type of Sponsor |
Government medical college |
|
|
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 Danish |
National Institute of Ayurveda Hospital |
OPD 04,28,32 and IPD, Department of Shalya Tantra, National Institute of Ayurveda hospital, Madhav Villas palace, Amer road
Jaipur
RAJASTHAN |
9756556388
qdanish513@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee National Institute of Ayurveda |
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 | Comparator Arm (Non Ayurveda) | | - | | Standard post operative care | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Yashtimadhu Ghrita, Reference: Susruta samhita sutra sthana chikitsa 38, Route: Oral, Dosage Form: Ghrita, Dose: 5(ml), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 14 Days, anupAna/sahapAna: Yes(details: Luke warm water), Additional Information: with standard post operative care |
|
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients diagnosed with primary inguinal hernia indicated for open repair
ASA grade I and II patients |
|
| ExclusionCriteria |
| Details |
Recurrent or complicated hernia cases
Patients with coagulation disorders or chronic inflammatory diseases
Patients with pacemakers or implantable electronic devices (contra
indicated for electrosurgery groups) |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Post operative pain (Visual analogue scale)
Incidence of postoperative complications (seroma, hematoma, and purulent
discharge)
• Presence of hyperaemia, ecchymosis, and local temperature variations using an
IR thermometer.
• Wound healing efficiency (Time to complete epithelialization) |
Assessment will be done on base line 2,6,10 and 14 post operative day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Duration of hospital stay
Quality of life assessment by EuraHS QoL score |
asseessment will be done on base line & 30 day post operatively |
|
|
Target Sample Size
|
Total Sample Size="42"
Sample Size from India="42"
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)
|
30/01/2026 |
| 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="3"
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
|
Hernias of the abdominal wall have a global prevalence of approximately 7.7%, affecting individuals of all age groups. Open inguinal hernia repair remains a commonly performed surgical procedure, with techniques evolving to minimize complications and enhance postoperative recovery. Despite the advent of laparoscopic and Lichtenstein mesh repairs, open techniques are still widely used due to their accessibility and cost-effectiveness.In this trial we are enrolling 42 patients in 2 divided groups as a Group A and Group B . In this Group A (n=21): Hernia repair (Lichtenstein’s procedure) using monopolar cautery. Yashtimadhu Ghrita for 3 days pre procedure and for 10 days after 24 hours post procedure and Group B (n=21): Hernia repair (Lichtenstein’s procedure) using monopolar cautery. |