| CTRI Number |
CTRI/2025/07/089981 [Registered on: 02/07/2025] Trial Registered Prospectively |
| Last Modified On: |
02/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A Controlled Trial to Compare the
Efficacy of Jeemutak Varti and Corect Suppository in
The Reduction of Size of Grade I And Grade II piles
w.s.r. to Abhyantar Arsha |
|
Scientific Title of Study
|
A Randomized Controlled Trial to Compare the
Effectiveness of Jeemutak Varti and Corect Suppository in
The Reduction of Size of Grade I And Grade II Haemorrhoids
w.s.r. to Abhyantar Arsha |
| 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 LOCHAN SINGH KHANDAGALE |
| Designation |
Ph.D SCHOLAR , Associate Professor |
| Affiliation |
SHRI AYURVED MAHAVIDAYALAYA AND PAKWSA SAMNVAYA RUGNALAYA |
| Address |
Shalya Tantra Opd No. 07 Pakwasa Samnvaya Rugnalaya Shri Ayurved Mahavidayalya
Dhanwantri Marg Hanuman Nagar Nagpur Maharastra
Shalya Tantra Opd No. 07 Pakwasa Samnvaya Rugnalaya Shri Ayurved Mahavidayalya
Dhanwantri Marg Hanuman Nagar Nagpur Maharastra
Nagpur
MAHARASHTRA
440009
India |
| Phone |
9425664699 |
| Fax |
|
| Email |
drlochan999@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR JYOTI NILKANTHA SHINDE |
| Designation |
HOD AND PROFESSOR |
| Affiliation |
SHRI AYURVED MAHAVIDAYALAYA AND PAKWSA SAMNVAYA RUGNALAYA |
| Address |
Shalya Tantra Opd No. 07 Pakwasa Samnvaya Rugnalaya Shri Ayurved Mahavidayalya
Dhanwantri Marg Hanuman Nagar Nagpur Maharastra
Shalya Tantra Opd No. 07 Pakwasa Samnvaya Rugnalaya Shri Ayurved Mahavidayalya
Dhanwantri Marg Hanuman Nagar Nagpur Maharastra
Nagpur
MAHARASHTRA
440009
India |
| Phone |
9975830051 |
| Fax |
|
| Email |
drjyoti.dalal@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR LOCHAN SINGH KHANDAGALE |
| Designation |
Ph.D SCHOLAR , Associate Professor |
| Affiliation |
DHANWANTRI MARG HANUMAN NAGAR NAGPUR MAHARASTRA |
| Address |
Shalya Tantra Opd No. 07 Pakwasa Samnvaya Rugnalaya Shri Ayurved Mahavidayalya
Dhanwantri Marg Hanuman Nagar Nagpur Maharastra
Shalya Tantra Opd No. 07 Pakwasa Samnvaya Rugnalaya Shri Ayurved Mahavidayalya
Dhanwantri Marg Hanuman Nagar Nagpur Maharastra
Nagpur
MAHARASHTRA
440009
India |
| Phone |
9425664699 |
| Fax |
|
| Email |
drlochan999@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
shri ayurved mahavidayala pakwasa and samanvaya rugnalaya nagpur |
| Address |
Shalya Tantra Opd No. 07 Pakwasa Samnvaya Rugnalaya Shri Ayurved Mahavidayalya
Dhanwantri Marg Hanuman Nagar Nagpur Maharastra
|
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| dr lochan singh khandagale |
shri ayurved mahavidayala pakwasa and samanvaya rugnalaya nagpurDhanwantri Marg Hanuman Nagar nagpur Maharastra 440009 |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| lochan singh khandagale |
shri ayurved mahavidayala pakwasa and samanvaya rugnalaya nagpur |
Shalya Tantra Opd No. 07 Pakwasa Samnvaya Rugnalaya Shri Ayurved Mahavidayalya
Dhanwantri Marg Hanuman Nagar Nagpur Maharastra
Nagpur
MAHARASHTRA |
9425664699
drlochan999@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| institutional ethical commitiee report |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:K928||Other specified diseases of the digestive system. Ayurveda Condition: ARSAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Procedure | - | gudavarti गुदवित Pradhan Karma | (Procedure Reference: 81, Procedure details: 1. Under all aseptic precautions, under appropriate anesthesia, the patient will
laid down in lithotomy position.
2. Painting of perianal area will be done.
3. Then, as lit proctoscope lubricated with LOX jelly will be introduced in the
anal canal.
5. Pile mass will be identified and cleaned with dry gauze.
6. Jeemutak varti will be inserted into anal canal with lox 2% jelly)
(1) Medicine Name: jeemutak guda varti, Reference: 81, Route: Rectal, Dosage Form: Varti/ Suppository, Dose: 1(mg), Frequency: od, Duration: 7 Days |
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1) Diagnosed patients of I and II grade Haemorrhoids in the age group of 20-60 yrs.
2) Selection will be irrespective of gender, religion, education and socio-economic
status of the patients. |
|
| ExclusionCriteria |
| Details |
1) Patients with grade III and IV degree Haemorrhoids.
2) Patients suffering from different pathologies of anal canal and rectum like
carcinoma rectum and anal canal, ulcerative colitis, proctitis etc.
3) Patients with uncontrolled diabetes mellitus, immune-compromised, liver
cirrhosis patients.
4) Known patients of portal hypertension will be excluded |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| it is expected to end of the study we should able to Know the effcacy of ayurvedic treatment protocol in the managment of second degree hemorroids |
it is expected to end of the study we should able to Know the effcacy of allopathic suppository treatment protocol in the managment of second degree hemorroids |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| it is expected to end of the study we should able to Know the effcacy of allopathic suppository treatment protocol in the managment of second degree hemorroids |
it is expected to it take 1 year & 8 months |
|
|
Target Sample Size
|
Total Sample Size="64"
Sample Size from India="64"
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 1 |
|
Date of First Enrollment (India)
|
25/07/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
31/07/2025 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="8"
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 study aims to compare the clinical efficacy of Jeemutak Varti, a classical Ayurvedic formulation, and Corect Suppository, a modern pharmaceutical formulation, in managing Grade I and Grade II internal hemorrhoids (Abhyantar Arsha).A randomized controlled trial was conducted on 64 patients, equally divided into two groups. Group A received Jeemutak Varti and Group B received Corect Suppository per rectum for 14 days. Parameters such as pile mass size, pain, bleeding per rectum, and discomfort were assessed before, during, and after treatment. The study seeks to provide a comparative understanding of traditional and modern therapeutic approaches in Arsha Chikitsa |