| CTRI Number |
CTRI/2022/10/046286 [Registered on: 07/10/2022] Trial Registered Prospectively |
| Last Modified On: |
28/09/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Durvasidhhaghruta In Pain Management Of Parikartika . |
|
Scientific Title of Study
|
Randomized Open Controlled Clinical Study To Assess The Efficacy Of Durvasidhhaghruta In Pain Management Of Parikartika W.S.R 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 Praveen Kumar Mishra |
| Designation |
PG Scholar |
| Affiliation |
Yashwant Ayurvedic Medical College PGT and RC kodoli, shalyatantra department opd no 4 |
| Address |
Yashwant Ayurvedic Medical College PGT and RC kodoli,
Shalyatantra Department OPD No 4
Kolhapur
MAHARASHTRA
416114
India |
| Phone |
9404589106 |
| Fax |
|
| Email |
pkaipmt2013@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Suyog Patil |
| Designation |
Reader |
| Affiliation |
Yashwant Ayurvedic Medical College PGT and RC kodoli, shalyatantra department opd no 4 |
| Address |
Yashwant Ayurvedic Medical College PGT and RC kodoli,
Shalyatantra Department OPD No 4
Kolhapur
MAHARASHTRA
416114
India |
| Phone |
9823190222 |
| Fax |
|
| Email |
drsuyog0222@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Suyog Patil |
| Designation |
Reader |
| Affiliation |
Yashwant Ayurvedic Medical College PGT and RC kodoli, shalyatantra department opd no 4 |
| Address |
Yashwant Ayurvedic Medical College PGT and RC kodoli,
Shalyatantra Department OPD No 4
Kolhapur
MAHARASHTRA
416114
India |
| Phone |
9823190222 |
| Fax |
|
| Email |
drsuyog0222@gmail.com |
|
|
Source of Monetary or Material Support
|
| Yashwant Ayurvedic Medical College PGT and RC kodoli dist kolhapur Maharashtra |
|
|
Primary Sponsor
|
| Name |
Dr Praveen Kumar Mishra |
| Address |
Yashwant Ayurvedic Hospital Kodoli Kolhapur |
| 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 Praveen Kumar Mishra |
Yashwant Ayurvedic Medical College PGT and RC kodoli |
Shalyatantra Department opd no 4
Kolhapur
MAHARASHTRA |
9404589106
pkaipmt2013@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Commitee |
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, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Durvasidhaghruta, Reference: Bhaisajya Ratnavali, Route: Rectal, Dosage Form: Ghrita, Dose: 0(NA), Frequency: sos, Bhaishajya Kal: Pragbhakta, Duration: 15 Days, anupAna/sahapAna: No, Additional Information: | | 2 | Comparator Arm (Non Ayurveda) | | - | Lignocaine jelly 2% | Local Application Of Lignocaine Jelly 2% Twice Daily
for 15 Days. |
|
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1) Patients Having Classical Features Of Acute Fissure - In - Ano Namely Excruciating Pain In Anal Region During And After Defecation, Bleeding Per Anus, Constipation, Burning Sensation And With A Longitudinal Ulcer In The Anal Region Will Be Selected.
2) Acute Solitary Fissures Will Be Included.
3) Patients Suffering From Mild To Moderate Pain
|
|
| ExclusionCriteria |
| Details |
1) Patients Suffering From Chronic Fissure - In -Ano.
2) Patients Suffering From Any Other Ano Rectal Diseases.
3) Patients Suffering From Systemic Disorders Like HTN , DM etc
4) Patient Suffering From Infectious Disease Like HIV, Tuberculosis .
5) Any Malignancy
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Decrease In Symptoms Like Pain. |
15 Days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Increase healing of wound |
15 Days |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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/ Phase 3 |
|
Date of First Enrollment (India)
|
15/10/2022 |
| 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
|
None yet. |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This study is a Randomized
Open Controlled Clinical Study To Assess The Efficacy Of
Durvasidhhaghruta In Pain Management Of Parikartika W.S.R To Acute
Fissure In Ano .Study will be carried in OPD of Shalyatantra department of Yashwant Ayurvedic College and Hospital Kodoli. The observation would be drawn on the basis of symptoms after treatment given. |