| CTRI Number |
CTRI/2020/12/030028 [Registered on: 24/12/2020] Trial Registered Prospectively |
| Last Modified On: |
23/12/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Study held to see the effect of Acute fissure in Ano with Yashtimadhu tail comparison With Lignocaine 2% Ointment for Local Application. |
|
Scientific Title of Study
|
Randomized Clinical Study To Assess The Efficacy Of Yashtimadhutaila Pichu In Comparison With Lignocaine -2% Ointment In The Management Of Parikartika(Acute Fissure-In-Ano). |
| Trial Acronym |
Management Of Parikartika |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NILL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Ajay kumar anand |
| Designation |
MS Scholar Shalya tantra |
| Affiliation |
Dr D Y Patil College of ayurved pimpri pune |
| Address |
Opd no.3 of shlya tantra deparment in Dr D Y Patil college of ayurved and research center Pimpri Pune
OPD no 3 Dr D Y Patil college of ayurved and research center pimri pune
Pune
MAHARASHTRA
411018
India |
| Phone |
8318913948 |
| Fax |
|
| Email |
drajayanad24@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Pradeep kumar Jondhale |
| Designation |
M S Shalya tantra |
| Affiliation |
Dr D Y Patil College of ayurved pimpri pune |
| Address |
Opd no.3 of shlya tantra deparment in Dr D Y Patil college of ayurved and research center Pimpri Pune
Opd no.3 of shlya tantra deparment in Dr D Y Patil college of ayurved and research center Pimpri Pune
Pune
MAHARASHTRA
411018
India |
| Phone |
7499597529 |
| Fax |
|
| Email |
pbjondhale@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ajay kumar anand |
| Designation |
MS Scholar Shalya tantra |
| Affiliation |
Dr D Y Patil College of ayurved pimpri pune |
| Address |
Opd no.3 of shlya tantra deparment in Dr D Y Patil college of ayurved and research center Pimpri Pune
Opd no.3 of shlya tantra deparment in Dr D Y Patil college of ayurved and research center Pimpri Pune
Pune
MAHARASHTRA
411018
India |
| Phone |
8318913948 |
| Fax |
|
| Email |
drajayanad24@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr D Y Patil College Of Ayurved And Research Centre Sant Tukaram Ngar Pimpri Pune 411018.Maharshtra |
|
|
Primary Sponsor
|
| Name |
Dr Ajay kumar Anand |
| Address |
Dr D Y Patil College Of Ayurved And Research Centre Sant Tukaram Ngar Pimpri Pune 411018.Maharshtra |
| 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 Ajay kumar Anand |
Dr D Y Patil college of ayurved and research center pimri pune |
Opd no.3 of shlya tantra deparment in Dr D Y Patil college of ayurved and research center pimri pune
Pune
MAHARASHTRA |
8318913948
drajayanad24@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Research and Recognition committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:K628||Other specified diseases of anus and rectum. Ayurveda Condition: PARIKARTIKA, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Lignocaine -2 % oinment |
30 Patient will be treated with lignocaine - 2% ointment for follow up 0,7,14,21,28 (4weeks) |
| Intervention |
yashtimadhu tail pichu (size as per requirement) |
30 patient will be selected and treated with Yashtimadhu tail Pichu for follow up 0,7,14,21,28( 4 weeks) |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1)Patients having classical features of Fissure-in-ano namely excruciating pain in anal region during and after defaecation, bleeding per rectum, constipation, burning sensation, presence of sphincter spasm and with a longitudinal ulcer in the anal region will be selected.
2)Acute solitary fissures will be included.
3)Age group of 20-60 years
4)Patients suffering from parikartika(fissure in ano) as per Ayurvedic classics will be selected.
|
|
| ExclusionCriteria |
| Details |
1)Patients suffering from any other Ano rectal diseases.
2)Patients suffering from systemic disorders like HTN, DM etc.
3)Patient suffering from infectious disease like,tuberculosis.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1)Parikartika (fissure in ano) is one of the most common disorder of Ano-rectal disease’s.Acharyasushrut has mentioned the cardinal symptom of parikartika(fissure in ano).
2)To evaluate and establish safer,cost-effective Yashtimadhu tail in the management of Parkartika |
0,7,14,21,28 days (4 weeks) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Yashtimadhu Tail is the effective management of Parikartika(Fissure in Ano) |
4 weeks with 4 follow up
0,7,14,21,28 days(4weeks) |
|
|
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/ Phase 3 |
|
Date of First Enrollment (India)
|
30/12/2020 |
| 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 Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NILL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Aim of the study will be to give Ayurvedic Treatment to disease patient to improve his/her condition and we can give his/her cheap,safe side effect free management.The trail will be conducted on 60 patients for follow up 0,7,14,21 ,28 Days and doses of Yashtimadhu tail pichu twice in a day after Defecation for 4 weeks. |