| CTRI Number |
CTRI/2026/04/108648 [Registered on: 20/04/2026] Trial Registered Prospectively |
| Last Modified On: |
17/04/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Preventive |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A clinical study comparing two ayurvedic medicines aragawadha kapila avaleha and haritaki pippali avaleha for treating constipation in children age 3 to 6 years |
|
Scientific Title of Study
|
A Randomized Comparative Clinical trial to evaluate the efficacy of Aragwadha Kapila Avaleha and Haritaki Pippali Avaleha in the management of childhood constipation among pre school children aged 3 to 6 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 Karishma Shukla |
| Designation |
PG Scholar |
| Affiliation |
PDEAs College of Ayurveda and Research Centre Nigdi, Pune |
| Address |
PDEAs College of Ayurveda and Research Centre, Balrog Department,Nigdi, Pune, MAHARASHTRA, 411044
PDEAs College of Ayurveda and Research Centre, Balrog Department, Nigdi, Pune, MAHARASHTRA, 411044
Pune
MAHARASHTRA
411044
India |
| Phone |
8286080846 |
| Fax |
|
| Email |
karishmashukla40@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Madhavi Deodas |
| Designation |
HOD |
| Affiliation |
PDEAs College of Ayurved and Research Centre,Nigdi ,Pune |
| Address |
PDEAs College of Ayurveda and Research Centre, Nigdi, Pune, MAHARASHTRA, 411044
Pune
MAHARASHTRA
411044
India |
| Phone |
94230108181 |
| Fax |
|
| Email |
drdeodasms@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Madhavi Deodas |
| Designation |
HOD |
| Affiliation |
PDEAs College of Ayurved and Research Centre,Nigdi ,Pune |
| Address |
PDEAs College of Ayurveda and Research Centre, Balrog department, Nigdi, Pune, MAHARASHTRA 411044 India
Pune
MAHARASHTRA
411044
India |
| Phone |
94230108181 |
| Fax |
|
| Email |
drdeodasms@gmail.com |
|
|
Source of Monetary or Material Support
|
| PDEAs college of ayurveda and research centre nigdi pune |
| PDEAs college of ayurveda and research centre nigdi pune 411044 |
|
|
Primary Sponsor
|
| Name |
PDEAs college of ayurveda and research centre |
| Address |
PDEAs college of ayurveda and research centre Balrog department, nigdi, pune 411044 |
| 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 |
| Dr Karishma Shukla |
Ayurveda Rugnalaya and Sterling Multispeciality Hospital, Nigdi, Pradhikaran |
Ayurveda Rugnalaya and Sterling Multispeciality Hospital,Baalrog Department, OPD No. 118,Sector 27, Nigdi, Pradhikaran, Pune
Pune
MAHARASHTRA |
8286080846
karishmashukla40@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| PDEAS COLLEGE INSTITUTIONAL ETHICS COMMITTEE |
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: MALA-, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Aragwadh kapila avaleha, Reference: Bhavprakash, Route: Oral, Dosage Form: Avleha/Leha/Paka/Raskriya, Dose: 3(g), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 7 Days, anupAna/sahapAna: No, Additional Information: -nil
| | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Haritaki Pippali avaleha, Reference: Bhavprakash , Route: Oral, Dosage Form: Avleha/Leha/Paka/Raskriya, Dose: 3(g), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 7 Days, anupAna/sahapAna: No, Additional Information: nil |
|
|
|
Inclusion Criteria
|
| Age From |
3.00 Year(s) |
| Age To |
6.00 Year(s) |
| Gender |
Both |
| Details |
1)Diagnosed with functional constipation as per standard clinical or ROME IV
CRITERIA
2) Straining during more than 25% of defecations.
3) Lumpy or hard stools (Bristol stool Scale 1-2) more than 25% defecations.
4) Sensation of incomplete evacuation more than 25% defecations.
5)Presence of a large fecal mass in the colon
6) History of large diameter stools which may obstruct the toilet.
7) Associated symptoms- Abdominal pain, Anorexia. |
|
| ExclusionCriteria |
| Details |
1.Constipation due to organic or structural causes - Hirschsprug’s disease, piles.
2.Known case of cerebral palsy or constipation due to any other neuromuscular disorder.
3. Known case of hypothyroidism, Irritable Bowel Syndrome.
4.Children with severe abdominal pain.
5.Children with known case of any food allergy. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
To compare the efficacy of Aaragwadha Kapila Avaleha
and Haritaki Pippali Avaleha in relieving constipation, measured by
improvement in regulation in stool frequency and consistency, in preschool
children aged 3 to 6 years over 14 days. |
14 days of study with follow up on 3rd, 7th, 14th day. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To observe the adverse effects of the drug if any. |
14 days of study with follow up on 3rd, 7th, 14th day. |
|
|
Target Sample Size
|
Total Sample Size="33"
Sample Size from India="33"
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
|
N/A |
|
Date of First Enrollment (India)
|
28/04/2026 |
| 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
|
Childhood constipation is a common pediatric disorder affecting bowel habits and quality of life in preschool children. The majority of cases are functional in nature. In Ayurveda, childhood constipation can be correlated with Malavibandha, which occurs due to vitiation of Vata dosha and impaired Apana Vayu function leading to difficulty in defecation and hard stools. The present study is a randomized comparative clinical trial designed to evaluate and compare the efficacy of Aragwadha Kapila Avaleha and Haritaki Pippali Avaleha in the management of Malavibandha (functional constipation) in preschool children aged 3–6 years. A total of 66 children fulfilling Rome IV criteria for functional constipation will be randomly allocated into two groups. Group A will receive Aragwadha Kapila Avaleha and Group B will receive Haritaki Pippali Avaleha for a duration of 14 days. The outcome will be assessed based on improvement in stool frequency, stool consistency, painful defecation, and associated symptoms such as abdominal pain and anorexia. The study aims to provide scientific evidence for the efficacy and safety of these Ayurvedic formulations in the management of childhood constipation. |