| CTRI Number |
CTRI/2021/07/034992 [Registered on: 20/07/2021] Trial Registered Prospectively |
| Last Modified On: |
19/07/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A study of basti in Parikartika or Fissure in ano patients |
|
Scientific Title of Study
|
A Clinical study of Yashtayadi tail basti in the management of Parikartika w.s.r. to 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 Deepshri Bais |
| Designation |
PG Scholar |
| Affiliation |
Shree Narayan Prashad Awasthi government ayurved college |
| Address |
DEPT OF SHALYA TANTRA SHRI NARAYAN PRASHAD AWASTHI GOVT AYURVEDIC COLLEGE RAIPUR CHATTISGARH Raipur CHATTISGARH
Dept of Shalya tantra Shree Narayan Prashad Awasthi government ayurved college Raipur Chhattisgarh
pincode 492010
Raipur
CHHATTISGARH
492010
India |
| Phone |
9575232299 |
| Fax |
|
| Email |
deepshribais191@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Balendra singh |
| Designation |
Reader |
| Affiliation |
Shree Narayan Prashad Awasthi government ayurved college |
| Address |
Dept of Shalya tantra Shree Narayan Prashad Awasthi government ayurved college Raipur Chhattisgarh
pincode 492010
Dept of Shalya tantra Shree Narayan Prashad Awasthi government ayurved college Raipur Chhattisgarh
pincode 492010
Raipur
CHHATTISGARH
492010
India |
| Phone |
9039180335 |
| Fax |
|
| Email |
drbalendrasingh@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Uttam Kumar Nirmalkar |
| Designation |
Lecturer |
| Affiliation |
Shree Narayan Prashad Awasthi government ayurved college |
| Address |
Dept of Shalya tantra Shree Narayan Prashad Awasthi government ayurved college Raipur Chhattisgarh
pincode 492010
Dept of Shalya tantra Shree Narayan Prashad Awasthi government ayurved college Raipur Chhattisgarh
pincode 492010
Raipur
CHHATTISGARH
492010
India |
| Phone |
8234057199 |
| Fax |
|
| Email |
druk01508@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dept of Shalya tantra Shri Narayan prasad awasthi Govt Ayurved College Raipur Chhattisgarh |
|
|
Primary Sponsor
|
| Name |
Dr Deepshri Bais |
| Address |
SHREE NARAYAN PRASAD AWASTHI GOVT AYURVED COLLEGE RAIPUR CHATTISGARH |
| Type of Sponsor |
Other [Shree NPA government ayurved college raipur] |
|
|
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 |
| Deepshri Bais |
Shri Khudadad doongaji Govt Ayurved hospital Raipur CHATTISGARH india |
OPD no 15 dept of shalya tantra Shri khudadad doongaji Govt Ayurved hospital Raipur Chattisgarh india
Raipur
CHHATTISGARH |
9575232299
deepshribais191@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics 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
|
| Type |
Name |
Details |
| Comparator Agent |
Jatyadi ghrit |
Dose of Jatyadi ghrit- aacording to the condition of wound Rout of administration- locally Duration of application will be of 14 days |
| Intervention |
Yashtayadi tail basti |
Dose of Yashtayadi tail basti-48 mi once in a day Rout of administration- anal rout Duration of therapy will be of 14 days |
|
|
Inclusion Criteria
|
| Age From |
16.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Patient having classical feature of parikartika (fissure in ano)
2.Acute solitary fissure
3.Patients of age between of 18-60 year irrespective of gender, prakriti, religion etc.
|
|
| ExclusionCriteria |
| Details |
1. Ano-rectal abcess
2.Fistula-in-ano
3.Fissure-in-ano associated with TB,anal malignancy or malignancy
4.STDs, HIV, HbsAg, Hepatitis,uncontrolled case of DM and hypertension
5.Immunonological diseases like crohns disase, ulcerative colitis
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To increase healing process and relieving pain in fissure-in-ano |
Basti will be given for 14 days and follow up will be taken once in a week for 1 month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To reliving other associated symptoms like bleeding, constipation and burning sensation |
Basti will be given for 14 days and follow up will be taken once in a week for 1 month |
|
|
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 1 |
|
Date of First Enrollment (India)
|
22/07/2021 |
| 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="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
|
Fissure- in- ano is a most troubling and painful condition that affects a great majority of the population. Application of local anaesthetic, anal dilatation,fistulectomy and sphincterotomy are choice of treatment. A laxative is prescribed to ensure the motion is soft. This treatment procedure have their own limitation and also have postoperative complication like stenosis, incontinence etc. Hence, we require to take present study for more effective management of fissure in ano. In Ayuvedic classical books different type of Basti are mentioned for better wound healing, Yashtayadi taila basti is one of them , so I have decided to take Yashtayadi tail basti for intervention in fissure-in-ano |