| CTRI Number |
CTRI/2025/08/093038 [Registered on: 13/08/2025] Trial Registered Prospectively |
| Last Modified On: |
11/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A clinical trial to the study the effect of Abhayadi Gutika in management of Functional Constipation in children |
|
Scientific Title of Study
|
EVALUATION OF ABHAYADI GUTIKA IN MANAGEMENT OF VIBANDHA WITH SPECIAL REFERENCE TO FUNCTIONAL CONSTIPATION IN CHILDREN – A RANDOMISED
CONTROLLED CLINICAL TRIAL |
| 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 Khot Akshay Manik |
| Designation |
PG Scholar |
| Affiliation |
KLE Shri B M K ayurveda mahavidyalaya Shahapur Belgavi |
| Address |
Department of Kaumarabhritya KLE Shri B M Kankanawadi Ayurveda Mahavidyalaya Belgavi
Belgaum
KARNATAKA
590003
India |
| Phone |
9561678817 |
| Fax |
|
| Email |
akshaykhot1998@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Veena K H |
| Designation |
ASSOCIATE PROFESSOR |
| Affiliation |
KLE Shri BMKankanwadi Ayurveda Mahavidyalaya, Belagavi, Karnataka Belgaum |
| Address |
Department of Kaumarabhritya KAHER Shri B M Kankanawadi
Ayurveda Mahavidyalaya Belagavi Karnataka
Belgaum
KARNATAKA
590003
India |
| Phone |
09538469641 |
| Fax |
|
| Email |
dr.veenatonne@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Veena K H |
| Designation |
ASSOCIATE PROFESSOR |
| Affiliation |
KLE Shri BMKankanwadi Ayurveda Mahavidyalaya, Belagavi, Karnataka Belgaum |
| Address |
Department of Kaumarabhritya KAHER Shri B M Kankanawadi
Ayurveda Mahavidyalaya Belagavi Karnataka
Belgaum
KARNATAKA
590003
India |
| Phone |
09538469641 |
| Fax |
|
| Email |
dr.veenatonne@gmail.com |
|
|
Source of Monetary or Material Support
|
| KLE Ayurveda Hospital Shahapur Belagavi 590003, Karnataka |
|
|
Primary Sponsor
|
| Name |
KLE Ayurveda Hospital |
| Address |
KLE Shree B M Kankanawadi Ayurveda Mahavidyalaya Belagavi Karnataka |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Khot Akshay |
KLE Ayurveda Hospital |
OPD no 10 Department of Kaumarabhritya KLE Shri B M Kankanawadi Ayurveda Mahavidyalaya Belgaum
KARNATAKA
590003
INDIA
Belgaum
KARNATAKA |
9561678817
akshaykhot1998@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee for Research on Human Subject KAHERs Shri B M Kankanawadi Ayurveda Mahavidyalaya And KLE Ayurveda Hospital Shahapur Belgavi |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:K590||Constipation. Ayurveda Condition: VIBANDHA, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Abhayadi Gutika, Reference: Yogratnakara Sannipatatisara Chikitsa Adhyaya Shloka no 2, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 6(g), Frequency: hs, Bhaishajya Kal: Adhobhakta, Duration: 7 Days, anupAna/sahapAna: Yes(details: -Lukewarm water), Additional Information: - | | 2 | Comparator Arm (Non Ayurveda) | | - | Lactulose | Dose 1-2 gram/kg/day
orally
Once a day at Bedtime |
|
|
|
Inclusion Criteria
|
| Age From |
4.00 Year(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
Patients of either sex in age group between 4 years to 12 years and Patients fulfilling the diagnostic criteria and Children who are not on any medication for atleast 1 week |
|
| ExclusionCriteria |
| Details |
Children suffering from any known acute or chronic medical and surgical illness that might interfere the study for example acute GI infections or spinal cord lesions or Hirschsprung disease etc
And Children with any medications that may interfere with the result like laxatives or
purgatives etc will be excluded And Children on any medication or supplements causing constipation for example Iron supplements and Antidepressants and Diuretics And Children with Bleeding per rectum or mass per rectum etc that can interfere with the sudy will be excluded from the study |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
There might be significant effect of Abhayadi Gutika in the management of Vibandha in children with
Functional Constipation
measured by changes in the Bristol Stool Scale and Rome IV criteria and VAS
scale |
0th Day 3rd Day 7th Day 15th Day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
There might be significant effect of Abhayadi Gutika in the management of Vibandha in children with
Functional Constipation measured by Ayurvedic parameters of Vibandha |
0th Day 3rd Day 7th Day 15th Day |
|
|
Target Sample Size
|
Total Sample Size="34"
Sample Size from India="34"
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)
|
01/01/2026 |
| 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 Applicable |
| 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
|
Functional constipation is often described as difficult or infrequent bowel
movements / deviation from normal frequency, painful defecation, the passage
of hard stool and sensation of incomplete evacuation of stool Constipation is considered as one of the most common symptom of GI system.It
accounts for about 3% worldwide while in Asia this percentage lies in between
0.5% to 29.6%.Functional constipation in children lead to many gastrointestinal disorders such
as appendicitis, intussusception, ulcerative colitis etc. and associated symptoms
such as Abdominal pain (10-70%), Anorexia (10-25%), Incomplete
evacuation(30-50%) & Psychological problems(20%). Constipation leads to fecal incontinence, painful defecation and hard stools,
which are concerning problems in children as it hinders with their day-to-day
life.Commonest treatment modality are Laxatives, which when given frequently
leads to side effects, such as bloating , abdominal cramps or pain, nausea,
vomiting, diarrhea, fluid and electrolyte changes, and can be habit forming in
children. Hence there is a need for alternative modality of treatment for
constipation in children. In Ayurveda various drugs have been mentioned which have Anulomana,
Bhedana, deepana ,pachana karma and can have multidimensional effect to
reduce the signs and symptoms of vibandh. Abhayadi Gutika is one of the drug
mentioned in classics which includes karmas like Anulomana, deepana and
pachana. Therefore, this study is undertaken for the management of Vibandh in
children. |