| CTRI Number |
CTRI/2024/05/067267 [Registered on: 14/05/2024] Trial Registered Prospectively |
| Last Modified On: |
29/11/2025 |
| 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
|
Effect Of Shigru Nirgundi Ghan Capsule After Surgery Of Piles |
|
Scientific Title of Study
|
A Randomized Controlled Trial To Evaluate The Efficacy Of Shigru- Nirgundi Ghan Capsule In Postoperative Pain W.S.R. To Raktarsha |
| 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 Aishwarya PR |
| Designation |
P G Scholar |
| Affiliation |
National Institute Of Ayurveda, Deemed To Be University (De-Novo) |
| Address |
Deptartment Of Shalya Tantra, National Institute Of Ayurveda,
Deemed To Be University(De-Novo),
Jorawar Singh Gate,Amer Road, Jaipur, Rajasthan
Pin 302002
Jaipur
RAJASTHAN
302002
India |
| Phone |
9664437095 |
| Fax |
|
| Email |
praishwarya26@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ashok Kumar |
| Designation |
Professor |
| Affiliation |
National Institute Of Ayurveda, Deemed To Be University (De-Novo) |
| Address |
Deptartment Of Shalya Tantra, National Institute Of Ayurveda,
Deemed To Be University(De-Novo),
Jorawar Singh Gate,Amer Road, Jaipur, Rajasthan
Pin 302002
Jaipur
RAJASTHAN
302002
India |
| Phone |
9649180572 |
| Fax |
|
| Email |
ashok_hp1976@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Aishwarya PR |
| Designation |
P G Scholar |
| Affiliation |
National Institute Of Ayurveda, Deemed To Be University (De-Novo) |
| Address |
Deptartment Of Shalya Tantra, National Institute Of Ayurveda,
Deemed To Be University(De-Novo),
Jorawar Singh Gate,Amer Road, Jaipur, Rajasthan
Pin 302002
Jaipur
RAJASTHAN
302002
India |
| Phone |
9664437095 |
| Fax |
|
| Email |
praishwarya26@gmail.com |
|
|
Source of Monetary or Material Support
|
| National Institute of Ayurveda Deemed To Be University (De-Novo)
Jorawar Singh Gate Amer Road Jaipur Rajasthan – 302002 |
|
|
Primary Sponsor
|
| Name |
National Institute of Ayurveda |
| Address |
National Institute of Ayurveda Deemed To Be University (De-Novo)
Jorawar Singh Gate Amer Road Jaipur Rajasthan – 302002 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 AISHWARYA PR |
NATIONAL INSTITUTE OF AYURVEDA HOSPITAL |
OPD NUMBER - 28
DEPARTMENT OF SHALYA TANTRA
National Institute of
Ayurveda, Deemed To
Be University
(De-Novo) Jorawar
Singh Gate, Amer
Road, Jaipur,
Rajasthan – 302002
Jaipur
RAJASTHAN
Jaipur
RAJASTHAN |
9664437095
praishwarya26@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee National Institute Of Ayurveda Deemed to be University Jorawar Singh Gate , Amer Road , Jaipur - 302002 , |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:K90-K95||Other diseases of the digestive system. Ayurveda Condition: ARSAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm (Non Ayurveda) | | - | Capsulated Diclofenac Sodium 50mg |
Capsulated Diclofenac Sodium 50 Mg Will Be Given To Post Operative Patients Of Raktarsha Thrice In Day .
|
|
|
|
Inclusion Criteria
|
| Age From |
16.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients undergoing surgical intervention for raktarsha of age between 16 – 60 years
irrespective of gender, religion etc.
Patients not requiring to be kept nil via mouth in postoperative period.
Willing to participate in the study.
Patient planned for arshabandhan technique(plication of hemorrhoidal mass) for bleeding piles |
|
| ExclusionCriteria |
| Details |
patients with antihypertensive,lipid lower medicines,thyroid disorders.
Patients requiring concomitant medication for other diseases in postoperative period
particularly for pain management
Patients habitual of using alcohol or other drugs.
Patients having known allergies to trial drugs.
All other surgical methods other than plication for bleeding hemorrhoids |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
overall improvement in post operative ano rectal pain using ayurvedic
intervention with comparison to diclofenac capsules |
pain assessment will be carried out 8 hourly for 5 days after operation. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| assessment of patient satisfaction after surgical procedure |
After post operative 5 th day. |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
Final Enrollment numbers achieved (Total)= "30"
Final Enrollment numbers achieved (India)="30" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
01/06/2024 |
| Date of Study Completion (India) |
10/10/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
10/10/2025 |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
|
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
|
Participants attending the OPD and IPD of the NIA hospital and satisfying the selection criteria will be selected. All the participants who voluntarily agree to participate and provide informed written consent for participation will be recruited in the study. Total 30 participants will be selected after details examination and divided in 2 group of 15 patients each as per study protocol. All Procedures will be executed done under aseptic condition. Patient will not be taken under follow up |