| CTRI Number |
CTRI/2025/06/089106 [Registered on: 18/06/2025] Trial Registered Prospectively |
| Last Modified On: |
17/06/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Other (Specify) |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Application of vasa Pratisarniya kshar in the management of abhyantara arsha ( internal haemorrhoids 1 st and 2nd degree |
|
Scientific Title of Study
|
clinical study to evaluate the efficacy of vasa Pratisarniya kshar in the management of abhyantara arsha w.s.r internal haemorrhoid (1 st and 2nd degree) |
| 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 Alok Kumar yadav |
| Designation |
MS PG Scholar |
| Affiliation |
Vaidya yagya dutt sharma Ayurved Mahavidyalaya Khurja Bulandshahar |
| Address |
OPD no 5 Department of shalya tantra Vaidya yagya dutt sharma Ayurved mahavidyalaya Khurja Bulandshahr
Bulandshahar
UTTAR PRADESH
203131
India |
| Phone |
9877938128 |
| Fax |
|
| Email |
dralokkumar387@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Elizabeth P John |
| Designation |
MS Ayurveda HOD of shalya tantra |
| Affiliation |
Vaidya yagya dutt sharma Ayurved Mahavidyalaya Khurja Bulandshahr |
| Address |
opp no 5 Department of shalya tantra Vaidya yagya dutt sharma Ayurved Mahavidyalaya Khurja
Bulandshahar
UTTAR PRADESH
203131
India |
| Phone |
9877938128 |
| Fax |
|
| Email |
elizajhn@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Elizabeth P John |
| Designation |
MS Ayurveda HOD of shalya tantra |
| Affiliation |
Vaidya yagya dutt sharma Ayurved Mahavidyalaya Khurja Bulandshahr |
| Address |
opp no 5 Department of shalya tantra Vaidya yagya dutt sharma Ayurved Mahavidyalaya Khurja
Bulandshahar
UTTAR PRADESH
203131
India |
| Phone |
9877938128 |
| Fax |
|
| Email |
elizajhn@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
| Vaidya yagya dutt sharma Ayurved Mahavidyalaya Khurja Bulandshahr Uttar Pradesh 203131 |
|
|
Primary Sponsor
|
| Name |
Dr Alok Kumar yadav |
| Address |
OPD no 5 Department of shalya tantra Vaidya yagya dutt sharma Ayurved Mahavidyalaya Khurja Bulandshahr |
| Type of Sponsor |
Other [Self] |
|
|
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 Alok Kumar yadav |
Vaidya yagya dutt sharma Ayurved Mahavidyalaya Khurja Bulandshahr Uttar Pradesh |
OPD no 5 Department of shalya tantra Vaidya yagya dutt sharma Ayurved Mahavidyalaya Khurja Bulandshahr
Bulandshahar
UTTAR PRADESH |
98779 38128
dralokkumar387@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Vaidya Yagya Dutt Sharma Ayurved Mahavidyalaya Khurja Bulandshahr Uttar Pradesh |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:K649||Unspecified hemorrhoids. Ayurveda Condition: ARSAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | kShArakarma, क्षारकर्म | (Procedure Reference: Sushrutha chikitsa sthanana chapter 6 shloka no 3, Procedure details: The whole procedure will be done in three steps purva karma - part preparation is done
pradhana karma - Pratisarniya Vasa kshar is applied with the help of Shalaka
(Spatula) on the entire haemorrhoidal cush
To see the changes wait for 100 Matras (i.e., one and half minute)
paschata karma - The anal pack will be removed after 6 hrs
And follow up will be done after every week for 3 weeks or 21 days )
(1) Medicine Name: Vasa, Reference: Sushrutha Sutra sthana chapter 11 shloka 12, Route: Topical, Dosage Form: Kshara, Dose: 3(g), Frequency: od, Duration: 3 Days |
|
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients having Arsha who are fulfilling my study criteria and who are willing to be selected will be enrolled
Patients with 1st and 2nd degree haemorrhoids
Patient of the age group above 30 years – below 60 years
Patient will be selected irrespective of sex
Patients who will be ready to give written consent
|
|
| ExclusionCriteria |
| Details |
Patients planning to conceive in near future[during course of trial]
Any congenital diseases like haemophillia
Patients with 3 degree, 4 degree or prolapsed piles
Pregnant women and Lactating mothers
Patients suffering from Thrombosed Piles mass,Ulcerative Colitis and CA rectum |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reduction in size of pile mass |
21 days or 3 week
The trial drug will be given for 3 weeks and follow up will be done after 3rd week |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Bleeding reduced per rectum and relief in burning sensation |
After analysing all the parameters the result will be assessed on the basis of symptomatic relief and improvement.
Partially improvement after 7 days patient gets 30 percent relief from sign and symptoms
Improvement after 14 days patient gets 50-60 percent relief from sign and symptoms Cured after 21 days patient gets 80-100 percent relief from sign and symptoms. |
|
|
Target Sample Size
|
Total Sample Size="45"
Sample Size from India="45"
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)
|
05/07/2025 |
| 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="10"
Days="10" |
|
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
|
Arsha can be defined as dilated plexus of superior haemorrhoidal veins,in relation to anal canal.Due to indulgence in incompatible food,there is a diminution of agni leading to constipation and vegdharana which leads to pratilomgati of Apana vayu. There are several drugs for Arshas but here I have chosen Pratisarniya kshar which not only treat it’s symptoms but also does samprapti bhanga. Therefore I have selected 45 patients aged between 30-60 years,patients should be selected on the basis of inclusion and exclusion criteria . The trial will be of 21 days or 3 weeks follow up will be done after every week. Cured after 3rd week patient gets 80-100 percent from sign and symptoms |