| CTRI Number |
CTRI/2024/10/074629 [Registered on: 03/10/2024] Trial Registered Prospectively |
| Last Modified On: |
26/09/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Efficacy of Pratisarniya Kousataki kshar in the management of abhyantra Arshas |
|
Scientific Title of Study
|
Comparative clinical study to evaluate the efficacy of Pratisarniya Kousataki Kshar and Sclerotherapy in the management of abhyantra Arshas w.s.r to Haemorrhoids |
| 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 Avinash Kumar Singh |
| Designation |
PG Scholar |
| Affiliation |
Vaidya Yagya Dutt Sharma Ayurved Mahavidhalaya Khurja district Bulandshahar GT road |
| Address |
OPD Number 5 Department of Shalya Tantra Vaidya Yagya Dutt Sharma Ayurved Mahavidhalaya Dharpa Khurja Bulandshahar GT Road
Bulandshahar
UTTAR PRADESH
203131
India |
| Phone |
9456436946 |
| Fax |
|
| Email |
avinash29893@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Amit Mishra |
| Designation |
Professor Shalya Tantra Department |
| Affiliation |
Vaidya Yagya Dutt Sharma Ayurved Mahavidhalaya Khurja district Bulandshahar GT road |
| Address |
OPD Number 5 Department of Shalya Tantra Vaidya Yagya Dutt Sharma Ayurved Mahavidhalaya Dharpa Khurja Bulandshahar GT Road
PROFESSOR SHALYA TANTRA DEPARTMENT
Bulandshahar
UTTAR PRADESH
203131
India |
| Phone |
9838325000 |
| Fax |
|
| Email |
dramitkjjftp@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Amit Mishra |
| Designation |
Professor Shalya Tantra Department |
| Affiliation |
Vaidya Yagya Dutt Sharma Ayurved Mahavidhalaya Khurja district Bulandshahar GT road |
| Address |
OPD Number 5 Department of Shalya Tantra Vaidya Yagya Dutt Sharma Ayurved Mahavidhalaya Dharpa Khurja Bulandshahar GT Road
Bulandshahar
UTTAR PRADESH
203131
India |
| Phone |
9838325000 |
| Fax |
|
| Email |
dramitkjjftp@gmail.com |
|
|
Source of Monetary or Material Support
|
| Vaidya Yagya Dutt Sharma Ayurved Mahavidhalaya And PLRD Hospital Khurja Bulandshahar Uttar Pradesh |
|
|
Primary Sponsor
|
| Name |
Dr Avinash Kumar Singh |
| Address |
Vaidya Yagya Dutt Sharma Ayurved Mahavidhalaya Khurja district Bulandshahar GT road Bulandshahar Uttar Pradesh 203131 |
| Type of Sponsor |
Private medical college |
|
|
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 Avinash Kumar Singh |
Vaidya Yagya Dutt Sharma Ayurved Mahavidhalaya Khurja district Bulandshahar GT road |
OPD Number 5 Department of Shalya Tantra Vaidya Yagya Dutt Sharma Ayurved Mahavidhalaya Dharpa Khurja Bulandshahar GT Road
Bulandshahar
UTTAR PRADESH |
9456436946
aviash29893@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee Vaidya Yagya Dutt Sharma Ayurved Mahavidhalaya Khurja district Bulandshahar Uttar Pradesh |
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 |
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Day(s) |
| Age To |
60.00 Day(s) |
| Gender |
Both |
| Details |
1.Diagnosed case of 1st and 2nd degree Haemorrhoids
2.Patient with or without bleeding per rectum associated with Arsha
3.Patient who will be ready to give written consent.
|
|
| ExclusionCriteria |
| Details |
1.Diagnosed case of 3rd and 4rth degree Haemorrhoids
2.Patients suffering from concurrent systemic disease like Hypertension,Diabetes mellitus type 2.
3.Pregnant women and lactating mothers.
4.Patient suffering from thrombosed pile 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 |
| To evaluate the efficacy of Pratisarniya Kousataki Kshar in management of Abhyantra Arshas |
Maximum one month
the trial drug will be given on first day and patient will be called for follow up on 7th,14th,21st and 28th day
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To introduce the best & cost effective modality of treatment
decrease risk of recurrence &
fasten the recovery |
After analysing all parameters the result will be assessed on the basis of symptomatic relief & decrease in size of Pile mass |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
08/10/2024 |
| 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="9"
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
|
ARSHA A MAJOR PROBLEM IN TODAY’S MODERN WORLD DUE TO UNHEALTHY LIFESTYLE.ARSHA CAN BE DEFINED AS DILATED PLEXUS OF SUPERIOR HAEMORRHOIDAL VEINS IN RELATION TO ANAL CANAL.DUE TO INDULGENCE IN INCOMPATIBLE FOOD THERE IS DIMINUTION OF AGNI LEADING TO CONSTIPATION AND VEGADHARANA WHICH LEADS TO PRATILOMAGATI OF APANA VAYU LEADING TO AGNIMANDHYA AND CONSTIPATION.ARSHA GIVES SEVERE PAIN AND TROUBLE LIKE ENEMY THATS WHY IT IS MENTIONED AS ASHTOMAHAGADA IN SUSHRUT SAMHITA SUTRASTHANA AVARANIYA ADHYAYA 33.IN REGARD ACHARYA SUSHRUT STATES FOUR MODALITIES 1.)BHAISHAJYA CHIKITSA 2.)KSHARA KARMA 3.)AGNI KARMA 4.)SHASTRA KARMA.KSHARKARMA IS ONE OF THE BEST METHOD OF PRACTICE IN TREATMENT OF ARSHA. |