| CTRI Number |
CTRI/2025/07/090597 [Registered on: 09/07/2025] Trial Registered Prospectively |
| Last Modified On: |
09/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Other (Specify) [Curative] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To know the effect of Badara Churna in Vibandha (Functional Constipation) |
|
Scientific Title of Study
|
A randomised Control Clinical Study to Evaluate the Efficay Of Kola (Badara) choorna in the Management of Vibhanda in Children |
| 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 Ghuge Avinash Laxman |
| Designation |
PG Scholar |
| Affiliation |
Alvas Ayurveda medical college and hospital |
| Address |
Department of kaumarbhritya 3rd floor Alvas ayurveda medical college and hospital moodbidire Dakshin karnataka
Dakshina Kannada
KARNATAKA
574227
India |
| Phone |
7263072268 |
| Fax |
|
| Email |
avinashghuge1996@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Narayan Pai B |
| Designation |
Professor |
| Affiliation |
Alvas ayurveda medical college and hospital |
| Address |
Department of kaumarbhritya 3rd floor Alvas ayurveda medical college and hospital moodbidire Dakshin karnataka
Dakshina Kannada
KARNATAKA
574227
India |
| Phone |
9902329719 |
| Fax |
|
| Email |
drnarayanpai@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Narayan Pai B |
| Designation |
Professor |
| Affiliation |
Alvas ayurveda medical college and hospital |
| Address |
Department of kaumarbhritya 3rd floor Alvas ayurveda medical college and hospital moodbidire Dakshin karnataka
KARNATAKA
574227
India |
| Phone |
9902329719 |
| Fax |
|
| Email |
drnarayanpai@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dr Ghuge Avinash Laxman |
| Address |
Alvas ayurveda Medical college and hospital Moodbidire
Dakshina Kannada
Karnataka
574227
|
| 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 Ghuge Avinash Laxman |
Alvas ayurveda medical college and hospital |
Department of kaumarbhritya , 3rd floor. Alvas ayurveda medical college and hospital, moodbidire, Dakshin karnataka
Dakshina Kannada
KARNATAKA |
07263072268
avinashghuge1996@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethical commiittee alvas ayurveda medical college |
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: VIBANDHA, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Kola (Badara), Reference: Bhavprakash Section 1 Chapter 7/71-77, Route: Oral, Dosage Form: Churna/ Powder, Dose: 2.5(g), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 15 Days, anupAna/sahapAna: Yes(details: Jala), Additional Information: - | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Avipattikara Churna, Reference: Rasendra chintamani 18/34-40, Route: Oral, Dosage Form: Churna/ Powder, Dose: 2.5(g), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 15 Days, anupAna/sahapAna: Yes(details: Jala), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
6.00 Year(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
1. The children of either gender between the age group of 6-12 years.
2. Children fulfilling the ROME III criteria
3. Children presenting with symptoms, since 2 months. (as per ROME III criteria)
4. Whose parents are willing to give consent, will be registered for the clinical study.
|
|
| ExclusionCriteria |
| Details |
1. Children having constipation secondary to any of the other disease like hypothyroidism, hirschprung’s disease.
2. Presenting with any structural anomalies of anal canal.
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
to assess according to Rome III criteria
A. Painful defecation (Assessed by VAS)
B. Frequency of defecation
C. Number of episodes of fecal incontinence
D. Excessive stool retention
E. Hard bowel movement
F. Large fecal mass in the rectum
G. History of large diameter stools that may obstruct the toilet |
0th, 4th, 7th, 16, 22nd Day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| to assess Kshutmandya (reduced appetite), Udarashoola (Abdominal pain), Vilomascha Maruta (upward movement of flatus in the abdomen) |
0th, 4th, 7th, 16, 22nd Day |
|
|
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/ Phase 3 |
|
Date of First Enrollment (India)
|
20/07/2025 |
| 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 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 - NO
|
|
Brief Summary
|
Vibandha can
be corelated to constipation. According to Ayurvedic Classic texts; Vibandha
is a Sanga of Purisha caused due to vitiation of Apana Vayu
in Annavaha Srotas and Purishavaha Srotas. Majority of the children report constipation due to reduced intake of fiber and water, change in dietary habits, like eating chips, biscuits or other bakery products, improper toilet training, denying natural calls in the school or changing sleep pattern. A child with functional constipation may be healthy, yet has difficulty in defecation. If they are not treated timely, then leads to complications such as gaseous distension of abdomen, hemorrhoids, fissure in ano, rectal prolapse. Kola, a type of Badara explained in Bhavaprakasha Nighantu, and Kaiyadeva Nighantu in its Shushka form shows properties like Bhedaka, Agnivardhaka, and Saraka, which is helpful in samprapti vighatana of vibandha. Hence Shushka Kola (Badara) Choorna is taken as a trail drug. Avipattikara Choorna , explained in Rasendra Chintamani, which is a proven Vibandhahara yoga is taken as a standard drug. The children fulfilling the diagnostic and inclusion criteria will be enrolled for the study and further divided into 2 groups. Where Group A will be given Avipattikara churna and Group B will be given Kola(Badara) churna respectively. The assessment will be done as per Assessment criteria. Hence this work is intended to evaluate the efficacy of Shushka Kola (Badara) Choorna in the management of Vibandha in children. H01 –There is no statistically significant effect of Shushka Kola (Badara) Choorna in management of Vibandha in children. H1– There is statistically significant effect of Shushka Kola (Badara) Choorna in management of Vibandha in children. H02 –There is neither statistically significant difference between the effect of Shushka Kola (Badara) Choorna and Avipattikara Choorna, nor Shushka Kola (Badara) Choorna is better than Avipattikara Choorna in management of Vibandha in children. H2– There is statistically significant difference between the effect of Shushka Kola (Badara) Choorna and Avipattikara Choorna with Shushka Kola (Badara) Choorna showing better effect than Avipattikara Choorna in management of Vibandha in children. |