| CTRI Number |
CTRI/2025/05/086972 [Registered on: 15/05/2025] Trial Registered Prospectively |
| Last Modified On: |
14/05/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Application of kshar (a ayurvedic ointment) to treat piles. |
|
Scientific Title of Study
|
An Exploratory Comparative Study To Evaluate The Efficacy Of Tilwak Pratisaraniya Kshar And Vasa Pratisaraniya Application In The Management Of 2nd Degree Internal Hemorrhoids. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Saurabh Baburao Nikam |
| Designation |
MS SCHOLAR |
| Affiliation |
Post Graduate Institute of Ayurved Dr Sarvepalli Radhakrishnan Rajasthan Ayurved University Jodhpur |
| Address |
PG Department Of Shalya Tantra Post Graduate Institute of Ayurved Dr Sarvepalli Radhakrishnan Rajasthan Ayurved University Nagaur Road Karwar Jodhpur RAJASTHAN 342037
Jodhpur
RAJASTHAN
342037
India |
| Phone |
8999463599 |
| Fax |
|
| Email |
nikamsaurabh09@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof Dr Rajesh Kumar Gupta |
| Designation |
Prof and HOD |
| Affiliation |
Post Graduate Institute of Ayurved Dr Sarvepalli Radhakrishnan Rajasthan Ayurved University Jodhpur |
| Address |
PG Department Of Shalya Tantra Post Graduate Institute of Ayurved Dr Sarvepalli Radhakrishnan Rajasthan Ayurved University Nagaur Road Karwar Jodhpur RAJASTHAN 342037
Jodhpur
RAJASTHAN
342037
India |
| Phone |
9636520573 |
| Fax |
|
| Email |
guptadrrajeshkumargupta@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Prof Dr Rajesh Kumar Gupta |
| Designation |
Prof and HOD |
| Affiliation |
Post Graduate Institute of Ayurved Dr Sarvepalli Radhakrishnan Rajasthan Ayurved University Jodhpur |
| Address |
PG Department Of Shalya Tantra Post Graduate Institute of Ayurved Dr Sarvepalli Radhakrishnan Rajasthan Ayurved University Nagaur Road Karwar Jodhpur RAJASTHAN 342037
Jodhpur
RAJASTHAN
342037
India |
| Phone |
9636520573 |
| Fax |
|
| Email |
guptadrrajeshkumargupta@gmail.com |
|
|
Source of Monetary or Material Support
|
| Post Graduate Institute of Ayurved Dr Sarvepalli Radhakrishnan Rajasthan Ayurved University Nagaur Road Karwar Jodhpur RAJASTHAN 342037 |
|
|
Primary Sponsor
|
| Name |
Post Graduate Institute of Ayurved Dr Sarvepalli Radhakrishnan Rajasthan Ayurved University Jodhpur |
| Address |
PG Department Of Shalya Tantra Post Graduate Institute of Ayurved Dr Sarvepalli Radhakrishnan Rajasthan Ayurved University Nagaur Road Karwar Jodhpur RAJASTHAN 342037 |
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Dr Saurabh Nikam |
PG Department Of Shalya Tantra Post Graduate Institute of Ayurved Dr Sarvepalli Radhakrishnan Rajasthan Ayurved University Nagaur Road Karwar Jodhpur RAJASTHAN 342037 |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Saurabh nikam |
Sanjeevani Chikitsalaya |
Room No 14 PG Department Of Shalya Tantra Sanjeevani Chikitsalaya Dr Sarvepalli Radhakrishnan Rajasthan Ayurved University Nagaur Road Karwar Jodhpur 342037
Jodhpur
RAJASTHAN |
8999463599
nikamsaurabh09@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee Post Graduate Institute Of Ayurved Jodhpur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:K641||Second degree hemorrhoids. Ayurveda Condition: ARSAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Procedure | - | kShArakarma, क्षारकर्म | (Procedure Reference: Su.su.11/18-22, Procedure details: Application of kshar on internal hemorrhoids)
| | 2 | Comparator Arm | Procedure | - | kShArakarma, क्षारकर्म | (Procedure Reference: Su.su.11/18-22, Procedure details: Application of vasa kshar on internal hemorrhoids )
|
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patient presenting with complaints of second degree Arsh or Hemorrhoids which are bleeding per rectum and prolapse of pile mass and discharge and pruritus irrespective of region education and socioeconomic status are included in this study |
|
| ExclusionCriteria |
| Details |
Patients with other systemic illness like uncontrolled diabetes mellitus hypertension malignancy hepatitis HIV infected person tuberculosis pregnant women third and fourth degree internal piles external piles and other associated anorectal diseases |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Necrosis and degeneration of pile mass |
30 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Establish safety of tilwak and vasa kshar |
30 days |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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)
|
11/11/2025 |
| 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="0"
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
|
This is a interventional clinical comparative study to evaluate the efficacy of tilwak pratisaraniya kshar and vasa pratisaraniya kshar in the management of second degree internal hemorrhoids and primary outcome of this study is expected to be necrosis and degeneration of pile mass and secondary will be evaluate the safety of tilwak and vasa kshar. |