| CTRI Number |
CTRI/2023/01/048884 [Registered on: 11/01/2023] Trial Registered Prospectively |
| Last Modified On: |
10/01/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
"It is a study to see Effectiveness of Kshudrasevantika taila pichu and Doorvadi taila pichu in the management of Parikartika With Special Reference to Fissure in Ano" |
|
Scientific Title of Study
|
A Randomised Comparative Clinical Study To Evaluate The EEfficacy Of Kshudrasevantika (Tridex Procumbens Linn.)Taila Pichu And Doorvadi Taila Pichu In The Management Of Parikartika With Special Reference To Acute Fissure In Ano. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Diksha Parmar |
| Designation |
BAMS MS PG Scholar |
| Affiliation |
BLDEAs AVS AYURVEDA MAHAVIDYALAYA VIJAYAPURA |
| Address |
Dr Diksha Parmar PG Scholar, Department of Shalyatantra, BLDEAs AVS Ayurveda Mahavidyalaya, Hospital and Research Centre, vijayapura- 586109
Bijapur
India
Dr Diksha Parmar PG Scholar, Department of Shalyatantra, BLDEAs AVS Ayurveda Mahavidyalaya, Hoapital And Research Centre, Vijayapura- 586109
Bijapur
KARNATAKA
India
Bijapur
KARNATAKA
586101
India |
| Phone |
9380174080 |
| Fax |
|
| Email |
dikshaparmar82@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Prasadshakti GGannur |
| Designation |
professor and HOD |
| Affiliation |
BLDEAs AVS AYURVEDA MAHAVIDYALAYA VIJAYAPURA |
| Address |
Dr Prasadshakti G Gannur Professor and HOD Dept. of PG Studies in Shalyatantra BLDEAs AVS Ayurveda Mahavidyalaya, Hospital and Research Centre Vijayapura-586109
Bijapur
karnataka
586101
India
Dr Prasadshakti G Gannur Professor and HOD Dept. of PG Studies in Shalyatantra BLDEAs AVS Ayurveda Mahavidyalaya, Hospital and Research Centre Vijayapura-586109
Bijapur
karnataka
586101
India
Bijapur
KARNATAKA
586101
India |
| Phone |
9480062140 |
| Fax |
|
| Email |
pgannur@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Diksha Parmar |
| Designation |
MS Scholar Dept. of shalya tantra |
| Affiliation |
BLDEAs AVS AYURVEDA MAHAVIDYALAYA VIJAYAPURA |
| Address |
Dr Diksha parmar BLDEAs AVS Ayurveda Mahavidyalaya, Hospital and Research Centre Vijayapura-586109
Bijapur
karnataka
586101
India
Dr Diksha Parmar BLDEAs AVS Ayurveda Mahavidyalaya, Hospital and Research Centre Vijayapura-586109
Bijapur
karnataka
586101
India
Bijapur
KARNATAKA
586101
India |
| Phone |
9380174080 |
| Fax |
|
| Email |
dikshaparmar82@gmail.com |
|
|
Source of Monetary or Material Support
|
| BLDEAS AVS Ayurveda Mahavidyalaya |
|
|
Primary Sponsor
|
| Name |
BLDEAS AVS Ayurveda Mahavidyalaya |
| Address |
BLDEAS AVS Ayurveda Mahavidyalaya, Vidya Nagar, Bagalkot Road Vijayapura, Karnataka |
| 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 |
| Diksha Parmar |
BLDEAs AVS Ayurveda Hospital,Vijayapura |
Shalyatantra 11 OPD BLDEAS AVS Ayurveda Mahavidyalaya Hospital and Research Center Vijayapura,Karnataka
Bijapur
KARNATAKA |
9380174080
dikshaparmar82@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:K929||Disease of digestive system, unspecified. Ayurveda Condition: PARIKARTIKA, (2) ICD-10 Condition:K928||Other specified diseases of the digestive system. Ayurveda Condition: PARIKARTIKA, |
|
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Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | picu, पिचॠPradhan Karma | (Procedure Reference: su chikitsa 1/40, Procedure details: Sitz bath with luke warm water for fifteen minutes pateint in lithotomy position kshudra sevantika taila pichu is placed in anal verge & adviced to patient to keep it for 3 hours.A T bandage will be applied so that the pichu will be retained in situ till the desired duration )
(1) Medicine Name: kshudrasevantika taila, Reference: Indian medicinal plant, Route: Rectal, Dosage Form: Taila, Dose: 5(ml), Frequency: od, Duration: 21 Days | | 2 | Comparator Arm | Procedure | - | picu, पिचॠ| (Procedure Reference: su chikitsa 1/40, Procedure details: Sitz bath with luke warm water for fifteen minutes pateint in lithotomy position kshudra sevantika taila pichu is placed in anal verge & adviced to patient to keep it for 3 hours.A T bandage will be applied so that the pichu will be retained in situ till the desired duration )
(1) Medicine Name: Doorvadi taila, Reference: Yogratnakar, Route: Rectal, Dosage Form: Taila, Dose: 5(ml), Frequency: od, Duration: 21 Days |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Patient having classical features of acute fissure-in-Ano namely a longitudinal ulcer in the anal region with any one or more of the following features:
Excruciating pain in anal region during and after defecation,bleeding per anum,Constipation,burning sensation and presence of sphincter spasm will beselected
acute solitary fissure
patients of age group18-80 years of bothe gender |
|
| ExclusionCriteria |
| Details |
1.Patients with K/C/O Ulcerative colitis, Syphilis, Crohn’s disease, inflammatory bowel disease and other systemic disease pertaining to rectum and anal canal will be excluded from the study.
2.Acute multiple fissures will be excluded from the study.
3.Patient with chronic fissure in ano,ca of rectum,ca of anal canal, fistula in ano, hemorrhoids or any other ano-rectal diseases.
4.Patient with systemic disorders such as diabetes, tuberculosis.
5.HIV, HBsAg& HCV positive patients. |
|
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Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reduce in pain,burning sensation,bleeding per rectum and consitation |
21 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Reduction in ulcer size, improvement in the wound healing |
21 days |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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)
|
12/01/2023 |
| 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="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This study is randomized comparative clinical study to evaluate the efficacy of kshudrasevantika taila pichu over doorvadi taila pichu in the management of parikartika with special reference to acute fissure in ano that will be conducted in BLDEAS AVS Ayurveda Mahavidyalaya, hospital and research centre, vijayapura - 586106 karnataka, india |