| CTRI Number |
CTRI/2023/05/052705 [Registered on: 16/05/2023] Trial Registered Prospectively |
| Last Modified On: |
29/11/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Other (Specify) [in-silico] |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A study of chatuh sam yoga on vibandha in children |
|
Scientific Title of Study
|
In silico study and evaluation of clinical efficacy of chatuh Sam yoga in Vibandh. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Kiran Sahu |
| Designation |
PG scholar |
| Affiliation |
Shri Narayana Prasad Awasthi Government Ayurved College Raipur Chhattisgarh 492010 |
| Address |
Department of kaumarbhritya, shri NPA goverment ayurved collage raipur (c.g.)
Raipur
CHHATTISGARH
492010
India |
| Phone |
8223943725 |
| Fax |
|
| Email |
kiransahu1709@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Neeraj Agrawal |
| Designation |
Professor |
| Affiliation |
Shri Narayana Prasad Awasthi Government Ayurved College Raipur Chhattisgarh 492010 |
| Address |
Department of kaumarbhritya Shri Narayana Prasad Awasthi Government Ayurved College Raipur Chhattisgarh
Raipur
CHHATTISGARH
492010
India |
| Phone |
9827362458 |
| Fax |
|
| Email |
dr_neeraj2001in@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Lowkesh Chandravanshi |
| Designation |
lecturer |
| Affiliation |
Shri Narayana Prasad Awasthi Government Ayurved College Raipur Chhattisgarh 492010 |
| Address |
Department of kaumarbhritya Shri Narayana Prasad Awasthi Government Ayurved College Raipur Chhattisgarh
Raipur
CHHATTISGARH
492010
India |
| Phone |
8223943725 |
| Fax |
|
| Email |
lowkeshc@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of kaumarbhritya Shri Narayana Prasad Awasthi Government Ayurved College Raipur Chhattisgarh 492010 |
|
|
Primary Sponsor
|
| Name |
Department of kaumarbhritya Shri Narayana Prasad Awasthi Govt Ayurved College Raipur Chhattisgarh |
| Address |
Shri Narayana Prasad Awasthi Government Ayurved College Raipur Chhattisgarh 492010 |
| Type of Sponsor |
Government medical college |
|
|
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 |
| kiran sahu |
Shri Narayana Prasad Awasthi Government Ayurved College Raipur Chhattisgarh 492010 |
Department of kaumarbhritya, opd no. 7,
Raipur
CHHATTISGARH |
8223943725
kiransahu1709@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| institutional ethics committee govt. ayurveda collage raipur c.g. |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:K928||Other specified diseases of the digestive system. Ayurveda Condition: VIBANDHA, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Chatuh sam yaga, Reference: Bhayshjya ratnawali, Route: Oral, Dosage Form: Khanda /Granules, Dose: 1(g), Frequency: hs, Bhaishajya Kal: Adhobhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: -luke warm milk), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
2.00 Year(s) |
| Age To |
6.00 Year(s) |
| Gender |
Both |
| Details |
1.Children of both genders male/ female of age 02 to 06 years.
2.Two or less than two defecations in the toilet per week.
3.At least 1 episode of fecal incontinence per week.
4.History of painful and hard bowel movement.
|
|
| ExclusionCriteria |
| Details |
1.Children suffering from any severe systemic disease like kidney disease, heart disease.
2.Children having any congenital anomaly (anal stricture)
3.Who are not able to come at regular follow up
4.If constipation due to congenital gut motility disorder (Hirsch sprung disease)
|
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| 1.stool become soft and easily defecate. |
At baseline, 7th day and every 15 day for the period of 2 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Improve the quality of life |
60 days |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
Final Enrollment numbers achieved (Total)= "30"
Final Enrollment numbers achieved (India)="30" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
15/07/2023 |
| Date of Study Completion (India) |
10/09/2024 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Constipation is increasingly being recognized as a very common problem in children and it associated with both physical and psychological morbidity and a poor quality of life. It can be defined as a delay or difficulty in defecation, present for two or more weeks and sufficient to cause significant distress to the patient.In Ayurveda vibandha is derived from word ‘vi’ and ‘bandha’ that means binding of stools. Direct and explicit description of vibandh as a disease is not found in ayurveda samhitas. It is considered as a symptom in most of the annavaha and purishvaha srotovikriti. After complete digestion of food ahara rasa is absorb in duodenum and the kitt bhaga reach in large intestine in liquid state and water is absorb there than solid waste move to rectum and remove from their certain path. If stool becomes hard or less in quantity because extra water absorb due to vikrit vata and pitta. This condition is called vibandha. In classic, many herbs and herbominarals have been described which may help to treat vibandha (constipation).
Chatuhsam yoga is a unique combination of 3 herbs and gudh (jaggary) given in Ayurveda Samhita. |