| CTRI Number |
CTRI/2026/02/102961 [Registered on: 04/02/2026] Trial Registered Prospectively |
| Last Modified On: |
03/02/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A Clinical Study to Assess the Effectiveness of Shatavari Ghrita in Functional Constipation in Children Aged 5-10 Years |
|
Scientific Title of Study
|
A single arm clinical study to evaluate the efficacy of Shatavari Ghrita in the management of Vibandha (Functional Constipation) in Children (5-10 years) |
| 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 Dinesh Kumar |
| Designation |
PG Scholar |
| Affiliation |
Amrita School of Ayurveda |
| Address |
Department of Kaumarabhritya (OPD NO 6),Amrita School of Ayurveda and Hospital,Clappana PO
Department of Kaumarabhritya (OPD NO 6),Amrita School of Ayurveda and Hospital,Clappana PO,690525
Kollam
KERALA
690525
India |
| Phone |
9418754276 |
| Fax |
|
| Email |
dineshkaasav@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Kannan Sagar |
| Designation |
Associate Professor |
| Affiliation |
Amrita School of Ayurveda |
| Address |
Department of Kaumarabhritya (OPD no 6)
Amrita School of Ayurveda and Hospital, Vallikavu, Clappana (PO), District Kollam
Department of Kaumarabhritya (OPD no 6)
Amrita School of Ayurveda and Hospital, Vallikavu, Clappana (PO), District Kollam,690525
Kollam
KERALA
690525
India |
| Phone |
9496329687 |
| Fax |
|
| Email |
kannans@ay.amrita.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr Kannan Sagar |
| Designation |
Associate Professor |
| Affiliation |
Amrita School of Ayurveda |
| Address |
Department of Kaumarabhritya(OPD no 6), Amrita School of Ayurveda, Vallikavu, Clappana (PO), District Kollam
Department of Kaumarabhritya(OPD no 6),Amrita School of Ayurveda, Vallikavu, Clappana (PO), District Kollam,690525
Kollam
KERALA
690525
India |
| Phone |
9496329687 |
| Fax |
|
| Email |
kannans@ay.amrita.edu |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Amrita School of Ayurveda |
| Address |
Amrita School of Ayurveda,Vallikavu,District Kollam,Kerala 690525 |
| Type of Sponsor |
Other [Private Ayurvedic 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 |
| Dr Dinesh Kumar |
Amrita School of Ayurveda and Hospital |
Department of Kaumarabhritya (OPD No 6),Amrita School of Ayurveda and Hospital,Clappana PO,Vallikavu,Kollam,Kerala-690525
Kollam
KERALA |
9418754276
dineshkaasav@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| The Institutional Ethics Committee Amrita School of Ayurveda |
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, (2) 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: Shatavari Ghrita, Reference: Sahasryogam, Route: Oral, Dosage Form: Ghrita, Dose: 10.75(ml), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 14 Days, anupAna/sahapAna: Yes(details: Lukewarm milk), Additional Information: Age 5 years = 14ml
Age 6 years = 16ml
Age 7 years = 17.6ml approx. 17.5 ml
Age 8 years = 19.2ml approx. 19 ml
Age 9 years = 20.6ml approx. 20.5 ml
Age 10 years=21.6ml approx. 21.5 ml
Before food twice a day, in divided doses of 7ml, 8ml, 8.75ml, 9.5ml, 10.25ml and 10.75ml respectively as per age |
|
|
|
Inclusion Criteria
|
| Age From |
5.00 Year(s) |
| Age To |
10.00 Year(s) |
| Gender |
Both |
| Details |
Children of age group 5 to 10 years.
Parents who are ready to recruit their children in the trial and sign the informed consent form.
Participants fulfilling the Rome IV criteria
|
|
| ExclusionCriteria |
| Details |
Subjects with Hirschsprung’s disease, Hypothyroidism, Cerebral Palsy, Neurological disorders, Spinal cord abnormalities, Celiac disease, Anal stenosis, Anorectal malformation.
Subjects with ongoing acute illness and Gastrointestinal infections like Diarrhea, Amoebiasis, Worm infestations.
Subjects on Chronic laxative therapy, Steroids, Anticholinergics, or any medication known to cause Constipation.
Subjects with Psychiatric illness, Developmental Delay that may affect compliance |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Overall improvement in the symptoms of Vibandha (Functional constipation) after 14 days of intervention from baseline with Shatavari Ghrita in children (5-10 years).
Improvement in the frequency of bowel movement, nature of evacuation and stool consistency after 14 days of intervention from baseline with Shatavari Ghrita in children (5-10 years).
|
Baseline,Day 8,Day 15,Day 29
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Improvement in the lifestyle of children as per parent feedback after 14 days of intervention from baseline with shatavari Ghrita in children (5-10 years). |
Baseline,Day 8,Day 15,Day 29 |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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)
|
16/02/2026 |
| 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="0"
Months="11"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
.This is a single arm prospective clinical trial designed to evaluate the efficacy of Shatavari Ghrita in the management of Vibandha (functional constipation) in Children aged 5-10 years.Vibandha though not described as a seperate disease in Ayurveda,is explained through altered bowel functions due to Apana Vayu vitiation,Agnimandya,and Purishavaha Srotas Dushti and correlates with functional constipation described in modern medicine.Children diagnosed with functional constipation based on Rome IV criteria will receive oral Shatavari Ghrita for 14 days with assessment at baseline,Day 8,Day 15,Day 29.The primary outcomes include improvement in frequency of bowel movements,stool consistency,and nature of evacuation,while secondary outcome will be improvement in the lifestyle of children as per parent feedback after 14 days of intervention from baseline.The study aims to scientifically validate the traditional Ayurvedic use of Shatavari Ghrita as a safe and effective option for pediatric population with functional constipation. |