| CTRI Number |
CTRI/2022/12/048079 [Registered on: 13/12/2022] Trial Registered Prospectively |
| Last Modified On: |
21/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Study of large intestine in retention of faeces in relation with fecal calprotectin |
|
Scientific Title of Study
|
Study of pakvashaya pertaining to purishaja udavarta with reference to investigation range of fecal calprotectin |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Sachin Rangrao Patil |
| Designation |
Assistant Professor |
| Affiliation |
Bharati Vidyapeeth Deemed to be university College of Ayurved Pune |
| Address |
Department of Rachana Sharir Bharati Vidyapeeth Deemed to be University college of Ayurved Pune
Pune
MAHARASHTRA
411043
India |
| Phone |
9881901491 |
| Fax |
|
| Email |
drsachinp60@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Umesh Vamanrao Tekawade |
| Designation |
Professor and HOD |
| Affiliation |
Bharati Vidyapeeth Deemed to be university College of Ayurved Pune |
| Address |
Department of Rachana Sharir Bharati Vidyapeeth Deemed to be University college of Ayurved Pune
Pune
MAHARASHTRA
411043
India |
| Phone |
9423210319 |
| Fax |
|
| Email |
umesh.tekawade@bharatividyapeeth.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sachin Rangrao Patil |
| Designation |
Assistant Professor |
| Affiliation |
Bharati Vidyapeeth Deemed to be university College of Ayurved Pune |
| Address |
Department of Rachana Sharir Bharati Vidyapeeth Deemed to be University college of Ayurved Pune
Pune
MAHARASHTRA
411043
India |
| Phone |
9881901491 |
| Fax |
|
| Email |
drsachinp60@gmail.com |
|
|
Source of Monetary or Material Support
|
| Bharati Vidyapeeth Deemed to be University college of Ayurved Pune Satara Road Pune 43 |
|
|
Primary Sponsor
|
| Name |
Dr Sachin Rangrao Patil |
| Address |
Department of Rachana Sharir Bharati Vidyapeeth Deemed to be University college of Ayurved Pune |
| 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 Sachin Patil |
Bharati vidyapeeth (Deemed to be University)College of Ayurveda and hospital ,Satara road,Pune 43 |
Room No.04, Kayachikitsa
OPD, Bharati vidyapeeth(Deemed to be University) College of Ayurveda and Hospital,Satara road,Pune 43(India)
Pune
MAHARASHTRA |
9881901491
drsachinp60@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| [BV(DU)COA-EC] |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:K638||Other specified diseases of intestine. Ayurveda Condition: UDAVARTAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Lifestyle | - | - | Dinacarya: Kosnajal Reference:Astanga Samgraha Sutra Sthan Dravadravya Adhyaya 6/15, Route: Oral,Dose 10 ml, Ferquency:bd, Kal: Adhobhakta, Duration:21days, Anupana:50ml Kosnajal, Ritucarya: , Acara Rasayana:, Other:, Pathya/Apathya:no, Pathya:, Apathya: | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Eranda Taila, Reference: Charaka Samhita Chikitsa Sthan 26/29, Route: Oral, Dosage Form: Taila, Dose: 10(ml), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 21 Days, anupAna/sahapAna: Yes(details: 50 ml Kosnajal), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Selected 120 diagnosed patients of purishaja udavarta |
|
| ExclusionCriteria |
| Details |
Patients below 40 years and above 60 years Avirecya
Patients taken non-steroidal anti-inflammatory drugs.
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Assessment of pakvashaya is possible on the basis of investigation range of fecal calprotectin |
3 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Relieving of Mala sang and reduction in sign and symptoms of purishaja udavarta vyadhi
2.Effect of Eranda taila on gut biomarkers |
3 weeks |
|
|
Target Sample Size
|
Total Sample Size="120"
Sample Size from India="120"
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 |
|
Date of First Enrollment (India)
|
15/12/2022 |
| 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="2"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identiļ¬cation.
- What additional supporting information will be shared?
Response - Study Protocol
Response - Informed Consent Form
- Who will be able to view these files?
Response - Anyone
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response (Others) - Later on
- For how long will this data be available start date provided 15-12-2022 and end date provided 15-12-2024?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
Brief Summary
Modification(s)
|
This is a randomized parallel group placebo controlled trial to study effect of eranda taila on gut biomarker that is on fecal calprotectin. Purishaja udavarta vyadhi selected for the clinical observations for the purpose of the study after literature review. Considering the samprapti of purishaja udavarta the aushadhi like Eranda Taila is useful for sampratibhanga i.e.chikitsa. It is possible to access effect on gut biomarker range which is produced by the Eranda tail . Therefore, the study is planned to develop a new technique of assessment of the structures situated in pakvashaya by means of utilization of gut biomarker assessment. This study helps in early diagnosis of purishaja udavarta on basis of investigation range of fecal calprotectin.
|