| CTRI Number |
CTRI/2024/07/071599 [Registered on: 30/07/2024] Trial Registered Prospectively |
| Last Modified On: |
18/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Treating of piles with ayurvedic medicines and procedure |
|
Scientific Title of Study
|
Evaluation of the efficacy of Ardraka ksharasutra in the management of Arshas. |
| 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 Krishnaji Sadanand Patil |
| Designation |
pg scholar |
| Affiliation |
Alvas Ayurveda Medical College and Hospital, Moodubidre, Vidyagiri, Dakshina Kannada, Karnataka |
| Address |
PG Department of Shalya Tantra Alvas Ayurveda Medical College and hospital, Moodubidire, Vidyagiri, Dakshina kannada, Karnataka 574227
Dakshina Kannada KARNATAKA 574227
India
Dakshina Kannada
KARNATAKA
574227
India |
| Phone |
7348864093 |
| Fax |
|
| Email |
krishnapatil7348@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR SUKESH A |
| Designation |
PROFESSOR |
| Affiliation |
Alvas Ayurveda Medical College and Hospital, Moodubidre, Vidyagiri, Dakshina Kannada, Karnataka |
| Address |
PG Department of Shalya Tantra Alvas Ayurveda Medical College and hospital, Moodubidire, Vidyagiri, Dakshina kannada, Karnataka 574227
Dakshina Kannada KARNATAKA 574227
India
Dakshina Kannada
KARNATAKA
574227
India |
| Phone |
9845274680 |
| Fax |
|
| Email |
sukeshsdm@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Krishnaji Sadanand Patil |
| Designation |
pg scholar |
| Affiliation |
Alvas Ayurveda Medical College and Hospital, Moodubidre, Vidyagiri, Dakshina Kannada, Karnataka |
| Address |
PG Department of Shalya Tantra Alvas Ayurveda Medical College and hospital, Moodubidire, Vidyagiri, Dakshina kannada, Karnataka 574227
Dakshina Kannada KARNATAKA 574227
India
Dakshina Kannada
KARNATAKA
574227
India |
| Phone |
7348864093 |
| Fax |
|
| Email |
krishnapatil7348@gmail.com |
|
|
Source of Monetary or Material Support
|
| Alvas Ayurveda Medical College, Moodubidire |
|
|
Primary Sponsor
|
| Name |
Dr Krishnaji Sadanand Patil |
| Address |
Alvas Ayurveda Medical College and hospital, Moodubidire, Vidyagiri, Dakshina kannada, Karnataka 574227 |
| 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 Krishnaji Sadanand Patil |
Alvas Ayurveda Medical College |
OPD No5 PG Department of Shalya Tantra Alvas Ayurveda Medical College and hospital, Moodubidire, Vidyagiri, Dakshina kannada, Karnataka 574227
Dakshina Kannada
KARNATAKA |
7348864093
krishnapatil7348@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Clincal ethics commitee alvas ayurveda medical college vidyagiri moodbidri india |
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 | Comparator Arm | Procedure | - | kShArasUtra, कà¥à¤·à¤¾à¤°à¤¸à¥‚तà¥à¤° | (Procedure Reference: Chakradatta chapter 5/8, Procedure details: Transfixation and ligation by apamarga ksharasutra.
one time procedure
Duration along with follow up-60 days)
| | 2 | Intervention Arm | Procedure | - | kShArasUtra, कà¥à¤·à¤¾à¤°à¤¸à¥‚तà¥à¤° | (Procedure Reference: Chakradatta chapter 5/8, Procedure details: Transfixation and ligation by ardraka ksharasutra.
one time procedure
Duration along with follow up-60 days
)
|
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
The patients having classical symptoms of Arshas will be selected.
Patients will be selected between the age group of 18-70 yrs of either gender, irrespective of religion, occupation,
Socio-economic status.
Patients diagnosed with 2nd, 3rd and 4th degree internal haemorrhoids, Interno-external haemorrhoids, thrombosed haemorrhoids.
Controlled systemic illness like Hypertension and Diabetes mellitus |
|
| ExclusionCriteria |
| Details |
Patients suffering secondary to inflammatory diseases like Ulcerative colitis, Crohn’s disease.
Haemorrhoids associated with Fissure in Ano, Fistula in Ano, Anal stricture, Perianal abscess, Malignancy and Polyps.
Patients suffering from HIV, Tuberculosis and CA of rectum and Hepatitis B
Pregnant women.
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Effect of treatment will be assessed on the basis of gradation of both subjective and objective parameters before and after treatment.
Ruja (Post-operative Pain)
Srava (Discharge per rectum)
Rakta Srava (Bleeding P/R)
|
45th, 60th day
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
The Below Criteria will be Checked.
1.Tenderness
2.Sloughing & falling of pile mass
3.Wound healing
|
45th, 60th day |
|
|
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 2 |
|
Date of First Enrollment (India)
|
02/08/2024 |
| 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="1"
Months="6"
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 TRIAL WILL BE STARTED ONLY AFTER THE CTRI APPROVAL. PATIENTS WILL BE UNDER TRIAL IN BOTH THE GROUPS. KSHARASUTRA PREPARATION WILL BE DONE FOR THE GROUPS AND THE EFFICACY OF KSHARASUTRA IN THE MANAGEMENT OF ARSHAS WILL BE ASSESSED UNDER DEPARTMENTAL SUPERVISION AT THE INSTITUTION. |