| CTRI Number |
CTRI/2025/03/082484 [Registered on: 17/03/2025] Trial Registered Prospectively |
| Last Modified On: |
14/03/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Management of constipation in children through Ayurveda |
|
Scientific Title of Study
|
Clinical study to study the effect of Sukumara ghrita in the management of vibandha 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 |
Modhashree BS |
| Designation |
Student |
| Affiliation |
Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital,Hassan. |
| Address |
Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital Thanniruhalla BM Road Hassan Out Patient Department of Kaumarabhritya, Room Number 16 and 18
Hassan
KARNATAKA
573201
India |
| Phone |
9845945738 |
| Fax |
|
| Email |
ug20148@sdmcahhassan.org |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr.Vijayalaxmi Mallannavar |
| Designation |
Professor and HOD |
| Affiliation |
Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital,Hassan. |
| Address |
Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital Thanniruhalla BM Road Hassan Out Patient Department of Kaumarabhritya, Room Number 16 and 18
Hassan
KARNATAKA
573201
India |
| Phone |
9480624829 |
| Fax |
|
| Email |
drvijayalaxmim@sdmcahhassan.org |
|
Details of Contact Person
Public Query
|
| Name |
Dr.Vijayalaxmi Mallannavar |
| Designation |
Professor and HOD |
| Affiliation |
Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital,Hassan |
| Address |
Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital Thanniruhalla BM Road Hassan Out Patient Department of Kaumarabhritya, Room Number 16 and 18
Hassan
KARNATAKA
573201
India |
| Phone |
9480624829 |
| Fax |
|
| Email |
drvijayalaxmim@sdmcahhassan.org |
|
|
Source of Monetary or Material Support
|
| Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital,Thanniruhalla, Hassan- 573201 |
|
|
Primary Sponsor
|
| Name |
Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital,Thanniruhalla, Hassan- 573201 |
| Address |
Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital,Thanniruhalla, Hassan,Karnataka,India. |
| Type of Sponsor |
Private 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 |
| Modhashree BS |
Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital Thanniruhalla BM Road Hassan |
Out Patient Department of Kaumarabhritya,Room No 16 and 18,Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital,Thanniruhalla,BM Road Hassan- 573201
Hassan
KARNATAKA |
9845945738
-
ug20148@sdmcahhassan.org |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee,Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital,Thanniruhalla, Hassan |
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 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Sukumara Ghrita, Reference: Sahasrayoga, Route: Oral, Dosage Form: Ghrita, Dose: 10(ml), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 7 Days, anupAna/sahapAna: No, Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
2.00 Year(s) |
| Age To |
6.00 Year(s) |
| Gender |
Both |
| Details |
Children of either gender
Children aged between 2 to 6 years
Fulfilling the diagnostic criteria of Constipation
Parents who are willing to give assent |
|
| ExclusionCriteria |
| Details |
Children having constipation secondary to any of other disorders like hypothyroidism,hirschsprung disease
Structural anomalies of anal canal |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
The following parameters will be assessed.
Frequency of evacuation of stools
Nature of evacuation
Based on Bristol Stool chart
Mala Katinata
Alpamatra/muhurmuhu mala pravartana
Kashta/sashoolapravartana
Aruchi
Ajeerna
Udarashoola |
7th day
14th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
The following criteria will be assessed
1.Two or fewer defecations per week
2.Atleast 1 episode per week of incontinence after the acquisition of toileting skills
3. History of excessive stool retention and history of painful or hard bowel movements
4.Presence of a large fecal mass in the rectum
5.History of large- diameter stools that may obstruct the toilet |
Day 0
Day 7
Day 14 |
|
|
Target Sample Size
|
Total Sample Size="20"
Sample Size from India="20"
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)
|
01/04/2025 |
| 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="0"
Months="3"
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 is a very common Gastro-intestinal disorder presenting with difficulty in defecation,infrequent bowel movements and hard stools. Direct and explicit description of Vibandha as a disease is not found in Ayurveda but different presentation of Purisha,Ghana purisha,Sushka purisha,Mala avabaddhata are found in different contexts of Ayurveda,these can be taken as various manifestations of Vibandha.Vibandha occurs because of vitiation of Apanavata and it is considered as a prominent symptom in most of the Annavaha and Purishavaha sroto vikaras of children.The term Vibandha is explained as a prodromal symptom,compliaction in many of the diseases as Arsha,Udara roga,Vata vyadhi etc.But in contemporary sciences, it is explained as a separate disease of Gastro-intestinal system.
|