| CTRI Number |
CTRI/2024/06/069468 [Registered on: 25/06/2024] Trial Registered Prospectively |
| Last Modified On: |
21/06/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Other (Specify) [CLASSICAL] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A study to see the effect of doorvadi malahara over shaala malahara in the management of small tear of the lining that lines the anal opening. |
|
Scientific Title of Study
|
A Randomized Comparative Clinical Study To Evaluate The Efficacy Of Doorvadi Malahara Over Shaala Malahara In The Management Of Parikartika With Special Reference To Acute Fissure In Ano |
| 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 Shweta T Vambashe |
| Designation |
BAMS PG Scholar |
| Affiliation |
BLDEAs AVS Ayurveda Mahavidyalaya Hospital and Research Centre Vijayapur |
| Address |
Dept of PG Studies in Shalya Tantra BLDEAs AVS Ayurveda Mahavidyalaya Hospital and Research Centre Vijayapur
Bijapur
KARNATAKA
586109
India |
| Phone |
8951566123 |
| Fax |
|
| Email |
dr.shwetavambashe@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Aneesur Rehman Madni |
| Designation |
Associate Professor |
| Affiliation |
BLDEAs AVS Ayurveda Mahavidyalaya Hospital and Research Centre Vijayapur |
| Address |
Dept of PG Studies in Shalya Tantra BLDEAs AVS Ayurveda Mahavidyalaya Hospital and Research Centre Vijayapur
Bijapur
KARNATAKA
586109
India |
| Phone |
9538140448 |
| Fax |
|
| Email |
anees8804@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Aneesur Rehman Madni |
| Designation |
Associate Professor |
| Affiliation |
BLDEAs AVS Ayurveda Mahavidyalaya Hospital and Research Centre Vijayapur |
| Address |
Dept of PG Studies in Shalya Tantra BLDEAs AVS Ayurveda Mahavidyalaya Hospital and Research Centre Vijayapur
Bijapur
KARNATAKA
586109
India |
| Phone |
9538140448 |
| Fax |
|
| Email |
anees8804@gmail.com |
|
|
Source of Monetary or Material Support
|
| BLDEAs AVS Ayurveda Mahavidyalaya Vijayapur 586109 Karnataka India |
|
|
Primary Sponsor
|
| Name |
NIL |
| Address |
NIL |
| Type of Sponsor |
Other [NIL] |
|
|
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 Shweta T Vambashe |
BLDEAs AVS Ayurveda Mahavidyalaya Vijayapur |
OPD no 3 Dept of PG Studies in Shalya Tantra BLDEAs AVS Ayurveda Mahavidyalaya Vijayapur
Bijapur
KARNATAKA |
8951566123
dr.shwetavambashe@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee BLDEAs AVS Ayurveda Mahavidyalaya Hospital and Research Centre Vijayapur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:K600||Acute anal fissure. Ayurveda Condition: PARIKARTIKA, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Procedure | - | lepa, लेप | (Procedure Reference: Sushruta samhita sutra sthana chapter 18 shloka number 3, Procedure details: Shaala malahara will be applied once in a day in the morning hours after defecation.Patient in lithotomy position, the anus & perianal area will be cleaned with warm water & dried with a dry gauze and then approximately 2g of Shaala Malahara will be directly applied over the site of fissure with finger. )
(1) Medicine Name: Shaala malahara, Reference: Charaka samhita sutra sthana chapter 4 shloka 47, Route: Topical, Dosage Form: Malahara/ Ointment/ Balm, Dose: 2(g), Frequency: od, Duration: 21 Days(2) Medicine Name: Triphala choorna, Reference: Sharangdhar samhita madhyam khand chapter 6 shloka 9-10, Route: Oral, Dosage Form: Churna/ Powder, Dose: 10(g), Frequency: hs, Duration: 21 Days | | 2 | Intervention Arm | Procedure | - | lepa, लेप | (Procedure Reference: Sushruta samhita sutra sthana chapter 18 shloka number 3, Procedure details: Doorvadi malahara will be applied once in a day in the morning hours after defecation. Patient in lithotomy position, the anus & perianal area will be cleaned with warm water & dried with a dry gauze and then approximately 2g of Doorvadi Malahara will be directly applied over the site of fissure with finger. )
(1) Medicine Name: Doorvadi malahara, Reference: Charaka samhita chikitsa sthana chapter 25 shloka 93, Route: Topical, Dosage Form: Malahara/ Ointment/ Balm, Dose: 2(g), Frequency: od, Duration: 21 Days(2) Medicine Name: Triphala choorna, Reference: Sharangdhar samhita madhyam khand chapter 6 shloka 9-10, Route: Oral, Dosage Form: Churna/ Powder, Dose: 10(g), Frequency: hs, Duration: 21 Days |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients having classical features of Acute Fissure in Ano, namely a longitudinal ulcer in the anal region along with any one or more of the following features: excruciating pain in the anal region during and after defecation, bleeding per anum, constipation, burning sensation and presence of sphincter spasm will be selected. Acute solitary fissures. |
|
| ExclusionCriteria |
| Details |
Patients with K/C/O Ulcerative colitis, Syphilis, Crohns disease, Inflammatory bowel disease and other systemic disease pertaining to rectum and anal canal. Acute multiple fissures will be excluded from the study. Patient with chronic fissure in ano, Ca of rectum, Ca of anal canal, fistula in ano, haemorrhoids or any other ano rectal diseases. Systemic disorders such as diabetes, tuberculosis. Patients suffering from conditions like HIV, HBsAg and HCV positive patients. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Healing of the fissure(Ulcer)
Relieving of Pain and Burning sensation |
21 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Relieving of Tenderness, Sphincter spasm and Bleeding per anum |
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/ Phase 4 |
|
Date of First Enrollment (India)
|
15/07/2024 |
| 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="4"
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
|
This study is randomised comparative clinical study to evaluate the efficacy of Doorvadi Malahara over Shaala Malahara 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 Vijayapur 586109 Karnataka India |