| CTRI Number |
CTRI/2024/05/067166 [Registered on: 10/05/2024] Trial Registered Prospectively |
| Last Modified On: |
09/05/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Other (Specify) [Curative] |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
To know the effect of chitrakadi churna in Grahani Roga w.s.r to Irritable bowel syndrome. |
|
Scientific Title of Study
|
An Open Label Clinical Study To Know The Effectiveness Of Chitrakadi Churna In Grahani W.S.R to IBS |
| 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. Rashmisnata Dash |
| Designation |
Md (Ay.) scholar, Kayachikitsa |
| Affiliation |
Government Ayurvedic College and Hospital |
| Address |
Department of Kayachikitsa
OPD Room no-09
Government Ayurvedic College And Hospital, Kadamkuan, Patna.
Patna
BIHAR
800003
India |
| Phone |
8763664414 |
| Fax |
- |
| Email |
dash.rashmisnata1995@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Sujeet Kumar |
| Designation |
Assistant Professor |
| Affiliation |
Government Ayurvedic College And Hospital, Kadamkuan, Patna. |
| Address |
Department of Kayachikitsa
OPD Room no-09
Government Ayurvedic College And Hospital, Kadamkuan, Patna.
Patna
BIHAR
800003
India |
| Phone |
9123272204 |
| Fax |
- |
| Email |
drsujitkr@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr. Sujeet Kumar |
| Designation |
Assistant Professor |
| Affiliation |
Government Ayurvedic College And Hospital, Kadamkuan, Patna. |
| Address |
Department of Kayachikitsa
OPD Room no-09
Government Ayurvedic College And Hospital, Kadamkuan, Patna.
Patna
BIHAR
800003
India |
| Phone |
9123272204 |
| Fax |
- |
| Email |
drsujitkr@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government Ayurvedic College And Hospital,Kadamkuan,Patna,Bihar |
|
|
Primary Sponsor
|
| Name |
Dr Rashmisnata Dash |
| Address |
Government Ayurvedic College and Hospital,kadamkuan,Patna,Bihar,800003 |
| 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 |
| DrRashmisnata Dash |
Government Ayurvedic College and Hospital |
Department of Kayachikitsa,
OPD Room no-09,
Kadamkuan,Patna,Bihar,800003
Patna
BIHAR |
8763664414
-
dash.rashmisnata1995@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:K582||Mixed irritable bowel syndrome. Ayurveda Condition: GRAHANIDOSHAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Chitrakadi Churna, Reference: Yogratnakar samhita ,Grahani Rogaadhikar 4/60, Route: Oral, Dosage Form: Churna/ Powder, Dose: 3(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: Takra), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
17.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Age- Above 17yrs and below 70yrs.
Clinical features suggesting Grahani Roga.
Patients of conventional long therapy with no satisfactory response. |
|
| ExclusionCriteria |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Taken for assessment and subjective relief in symptoms i.e Muhurbaddha / Muhurdrava Mal pravriti
Arochaka
Trishna
Shoonpaadkarah
Asthiparvaruk
Chhardan
Udara Shoola
Shleshma mala pravriti
Atopa |
30 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Changes in CBC,ESR,
L.F.T., K.F.T,
Stool for occult blood and for parasites (if necessary)
|
30 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 2 |
|
Date of First Enrollment (India)
|
20/05/2024 |
| 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="0"
Months="8"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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 - 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 - Statistical Analysis Plan
Response - Informed Consent Form
Response - Clinical Study Report
Response - Analytic Code
Response - None of the above
- Who will be able to view these files?
Response - Anyone
- For what types of analyses will this data be available?
Response - Any purpose.
- By what mechanism will data be made available?
Response - Proposals should be directed to [dash.rashmisnata1995@gmail.com].
- For how long will this data be available start date provided 25-04-2025 and end date provided 15-03-2030?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
This study is a single arm open trial to knoow the effectiveness of Chitrakadi Churna in Grahani w.s.r. to IBS, that will be conducted in Goverenment Ayurvedic college and Hospital at Patna, Bihar in the department of Kayachikitsa in a group of 40 patients. After 15 days of intervention to follow up will be done in every 7days for total duration of study i.e. of 30days. |