| CTRI Number |
CTRI/2025/11/097792 [Registered on: 20/11/2025] Trial Registered Prospectively |
| Last Modified On: |
20/11/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
treatment of hemorroides using kshara lepana |
|
Scientific Title of Study
|
The efficacy of Pratisaraniyakshara in the management of Abhyantara arsa Arsa(second degree hemorrhoids) |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Indu P P |
| Designation |
Research Officer (Ay.) |
| Affiliation |
NARIP Cheruthuruthy |
| Address |
Room No A612, 6th floor
New hospital Building
Hospital section
Technical department
National Ayurveda research Institute for panchakarma ,Cheruthuruthy,Kerala
Thrissur
KERALA
679531
India |
| Phone |
9495312570 |
| Fax |
|
| Email |
dr.indupp@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Indu P P |
| Designation |
Research Officer (Ay.) |
| Affiliation |
NARIP Cheruthuruthy |
| Address |
Room No A612, 6th floor
New hospital Building
Hospital section
Technical department
National Ayurveda research Institute for panchakarma ,Cheruthuruthy,Kerala
Thrissur
KERALA
679531
India |
| Phone |
9495312570 |
| Fax |
|
| Email |
dr.indupp@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Indu P P |
| Designation |
Research Officer (Ay.) |
| Affiliation |
NARIP Cheruthuruthy |
| Address |
Room No A612, 6th floor
New hospital Building
Hospital section
Technical department
National Ayurveda research Institute for panchakarma ,Cheruthuruthy,Kerala
Thrissur
KERALA
679531
India |
| Phone |
9495312570 |
| Fax |
|
| Email |
dr.indupp@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
CCRAS |
| Address |
CCRAS Head Quarters, Janakpuri, New Delhi |
| Type of Sponsor |
Research institution |
|
|
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 Indu P P |
National Ayurveda Research Institute for Panchakarma Cheruthuruthy |
Room No A612, 6th floor
New hospital Building
Hospital section
Technical department
National Ayurveda research Institute for panchakarma ,Cheruthuruthy,Kerala
Thrissur
KERALA |
9495312570
dr.indupp@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| NARIP IEC |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:K628||Other specified diseases of anus and rectum. Ayurveda Condition: ARSAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | kShArakarma, क्षारकर्म | (Procedure Reference: AFI 466 Su Su 11:11 Su ci Arsa chikitsa, Procedure details: PratisharaniyaKshara with ApamargaKshara (TeekshnaKshara)
Local application, 2 gm-single sitting on Arsha
Position used is Lithotomy
Route of Administration is local application
it is done as single sitting & total Duration of therapy is 3 weeks
)
|
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients of second degree piles
Willing and able to give written informed consent
|
|
| ExclusionCriteria |
| Details |
Third degree ,Thrombosed & Strangulated pile mass (Hemorrhoids)
Bleeding diathesis
Cirrhosis of Liver- Portal hypertension
Ulcerative colitis and Crohn’s disease
Patients with evidence of malignancy
Patients on prolonged (greater 6 weeks) medication with corticosteroids, antidepressants, anticholinergic, immunosuppressant, estrogen replacement therapy etc. or any other drugs that may have an influence on the outcome of the study.
Patients suffering from major systemic illness necessitating long term drug etc.
Patients who have a past history of Atrial Fibrillation, Acute Coronary Syndrome,
Myocardial Infarction, Stroke or Severe Arrhythmia in the last 6 months.
Symptomatic patient with clinical evidence of Heart failure.
Patients having uncontrolled Diabetes Mellitus (Blood Sugar Fasting greater than 250mg/dl).
Patients with concurrent serious hepatic disorder (defined as aspartate aminotransferase (AST) and or alanine aminotransferase (ALT), total bilirubin or alkaline phosphatase (ALP) greater than 2 times upper normal limit) or renal disorders (defined as S.Creatinine greater than1.2mg per dL), severe pulmonary dysfunction (uncontrolled asthma and chronic obstructive pulmonary disease [COPD]), inflammatory bowel
Pregnant and lactating females.
Patients on oral contraceptives.
Alcoholics and or drug abusers.
History hypersensitivity to any of the trial drugs or their ingredients.
Patients who have completed participation in any other clinical trial during the past six (06) months.
Any other condition which the Investigator thinks may jeopardize the study
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.Change in Hemorrhoid Severity Score (HSS)
2.To assess the recovery time
3.Changes in colour of pile mass and assess post operative discharge
4.To assess the post operative complications like bleeding, pain, infection, stricture, incontinence
|
1.(baseline, 1st week,2nd week 3rd week , 8th week ,12th week and 16th week)
2.(1st week,2nd week 3rd week , 8th week ,12th week and 16th week)
3.(baseline, 1st week,2nd week 3rd week , 8th week ,12th week and 16th week )
4.(baseline, 1st week,2nd week 3rd week , 8th week ,12th week and 16th week)
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Assessment of safety by the incidence of reported treatment emergent adverse event
2.Assessment of the tolerability of the kshara karma through reported incidence of adverse events during the study period time frame
• Change in the laboratory safety parameters from baseline
• Change in the need of Rescue analgesic medication
• Patient satisfaction assessment
|
1.baseline, 7th day, 14th day 21st day
2.baseline, 7th day, 14th day, 21st day & 56th ,84th&112th day
3. base line and 112th day
4.baseline, 7th day, 14th day 21st day ,56th ,84th 112th day
5.7th day, 14th day 21st day, 56th ,84th &112th112th day
|
|
|
Target Sample Size
|
Total Sample Size="75"
Sample Size from India="75"
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)
|
01/04/2026 |
| 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="3"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
The study will be conducted in two phases. Phase one includes clinical consensus study for the SOP development of kshara nirmana and the pratisaraneeya kshara nirmana as per the developed SOP . In the second phase is clinical study for the efficasy of ksharakarma in the management of abhyantara arsa. ksharakarma will be done as per the SOP developed using the kshara prepared as per the SOP. sample size for the study is 75 and total duration is 112 days which includes 21 days of treatment period.Total trial duration is three yeras. |