| CTRI Number |
CTRI/2026/03/105805 [Registered on: 10/03/2026] Trial Registered Prospectively |
| Last Modified On: |
09/03/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Screening |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A Comparative study to evaluate the effect of Ayurvedic preparation Peelu Oil Ointment versus Ayurvedic preparation Apamarg Kshar Oil Ointment in Reducing size of Internal Pile mass in patients aged 18-60 years |
|
Scientific Title of Study
|
Effect of Peelu (Salvadora persica) taila malhara versus Apamarg kshar taila malhara in the management of Internal Haemorrhoids (Abhyantar Arsha) w.s.r. to reduction in size of Arsha: A Randomized Controlled 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 Muskan Gupta |
| Designation |
PG Scholar |
| Affiliation |
Shri Ayurved Mahavidyalaya, Nagpur |
| Address |
OPD NO 7, Shalyatantra Department, Pakwasa Samanvay Rugnalaya, Shri
Ayurved Mahavidyalaya, Dhanwantari Marg, Hanuman Nagar, Nagpur
Maharashtra
Nagpur
MAHARASHTRA
440024
India |
| Phone |
7582839181 |
| Fax |
|
| Email |
guptamuskan1504@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Jyoti Shinde |
| Designation |
Professor and HOD, Department of Shalyatantra |
| Affiliation |
Shri Ayurved Mahavidyalaya, Nagpur |
| Address |
OPD NO 7, Shalyatantra Department, Pakwasa Samanvay Rugnalaya, Shri
Ayurved Mahavidyalaya, Dhanwantari Marg, Hanuman Nagar, Nagpur
Maharashtra
Nagpur
MAHARASHTRA
440024
India |
| Phone |
9975830051 |
| Fax |
|
| Email |
drjyoti.dalal@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Muskan Gupta |
| Designation |
PG Scholar |
| Affiliation |
Shri Ayurved Mahavidyalaya, Nagpur |
| Address |
OPD NO 7, Shalyatantra Department, Pakwasa Samanvay Rugnalaya, Shri
Ayurved Mahavidyalaya, Dhanwantari Marg, Hanuman Nagar, Nagpur
Maharashtra
Nagpur
MAHARASHTRA
440024
India |
| Phone |
7582839181 |
| Fax |
|
| Email |
guptamuskan1504@gmail.com |
|
|
Source of Monetary or Material Support
|
| Shri Ayurved Mahavidyalaya Pakwasa Samanvay Rugnalaya Dhanwantari Marg Hanuman
Nagar Nagpur Maharashtra 440024 |
|
|
Primary Sponsor
|
| Name |
Shri Ayurved Mahavidyalaya, Nagpur |
| Address |
Shri Ayurved Mahavidyalaya Pakwasa Samanvay Rugnalaya Dhanwantari Marg Hanuman Nagar Nagpur Maharashtra 440024 |
| 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 Muskan Gupta |
Shri Ayurved Mahavidyalaya, Nagpur |
OPD NO 7, Shalyatantra
Department, Pakwasa
Samanvay Rugnalaya, Shri
Ayurved Mahavidyalaya,
Dhanwantari Marg, Hanuman
Nagar, Nagpur Maharashtra
440024
Nagpur
MAHARASHTRA
Nagpur
MAHARASHTRA |
7582839181
guptamuskan1504@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC of Shri Ayurved Mahavidyalaya |
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 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Peelu taila malhara, Reference: Govind Das Sen. Bhaishajya Ratnavali (Arsha Chikitsa). In: Tripathi I, editor. 20th ed. Varanasi: Chaukhambha Krishnadas Academy; 2007. p. 705., Route: Topical, Dosage Form: Malahara/ Ointment/ Balm, Dose: 3(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 21 Days, anupAna/sahapAna: No, Additional Information: - | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Apamarg kshar taila malhara, Reference: Bhaishajya Ratanvali by Siddhinandan Mishra, karnarogadhikar, 62/26, page no 969, Route: Topical, Dosage Form: Malahara/ Ointment/ Balm, Dose: 3(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 21 Days, anupAna/sahapAna: No, Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Diagnosed with 1st or 2nd-degree internal Hemorrhoids
Presenting with signs of inflammation (pain, swelling, redness)
Willing to provide informed consent
|
|
| ExclusionCriteria |
| Details |
Bleeding Disorder like Hemophilia etc.
Patient with uncontrolled systemic disease as like Diabetes Mellitus and Hypertension.
Patient with Carcinoma of Rectum.
Immune compromised Patients like AIDS, VDRL, Hepatitis B, Tuberculosis.
Patient having Parikartika secondary to Ulcerative colitis, Syphilis, Crohn’s disease.
Patient with severe spasm.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Peelu taila malhara may provide early reduction of size of internal Hemorrhoids than Apamarg kshar taila malhara in 21 days |
At the end of 21 days (1, 7, 14, 21 days) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| This may show reduction in local pain and bleeding per rectum in patients with Hemorrhoids |
At the end of 21 days (1, 7, 14, 21 days) |
|
|
Target Sample Size
|
Total Sample Size="68"
Sample Size from India="68"
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 3 |
|
Date of First Enrollment (India)
|
30/03/2026 |
| 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="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 study will be carried out at OPD of Shalyatantra Department of Pakwasa Samnvay Rugnalaya, Shri Ayurved Mahavidyalaya, Nagpur. This is an open label randomized controlledtrial aims at studying the comparison between effect of Peelu taila malhara and Apamarg kshar taila malhara in treatment of Arsha (Hemorrhoids). Total 68 patients will be included and will be randomly divided into two groups i.e. Group A and Group B each containing 34 patients. Group A will be trial group where patients will receive application of Peelu taila malhara and Group B will be the control group where patients will receive application of Apamarg kshar taila malhara. Then patients will be observed on 1,7th,14th and 21st day. All the findings will be recorded in case record form. At the end of trial, collected data will be analyzed and result will be drawn accordingly |