| CTRI Number |
CTRI/2025/09/094795 [Registered on: 15/09/2025] Trial Registered Prospectively |
| Last Modified On: |
12/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Evaluating two ayurvedic formulations for managing constipation in children. |
|
Scientific Title of Study
|
Comparative Clinical Evaluation Of
Shunthi Yog And Dadima Yog In Vibandha. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Little kumari |
| Designation |
PG Scholar |
| Affiliation |
Patanjali Bhartiya Ayurvigyan Evam Anusandhan Sansthan |
| Address |
Room no 402,dept of kaumarbhritya Patanjali Bhartiya Ayurvigyan Evam Anusandhan Sansthan
Room no 402 dept of kaumarbhritya Patanjali Bhartiya Ayurvigyan Evam Anusandhan Sansthan
Hardwar
UTTARANCHAL
249405
India |
| Phone |
7351637390 |
| Fax |
|
| Email |
littlechaudhary06@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr N Sujatha |
| Designation |
HOD and professor dept of kaumarbhritya |
| Affiliation |
Patanjali Bhartiya Ayurvigyan Evam Anusandhan Sansthan |
| Address |
Room no 402 dept of kaumarbhritya Patanjali Bhartiya Ayurvigyan Evam Anusandhan Sansthan
Room no 402 dept of kaumarbhritya Patanjali Bhartiya Ayurvigyan Evam Anusandhan Sansthan
Hardwar
UTTARANCHAL
249405
India |
| Phone |
9897828745 |
| Fax |
|
| Email |
sujatha.nunna@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Payal Thakur |
| Designation |
Assistant professor dept of kaumarbhritya |
| Affiliation |
Patanjali Bhartiya Ayurvigyan Evam Anusandhan Sansthan |
| Address |
Room no 402 dept of kaumarbhritya Patanjali Bhartiya Ayurvigyan Evam Anusandhan Sansthan
Room no 402 dept of kaumarbhritya Patanjali Bhartiya Ayurvigyan Evam Anusandhan Sansthan Haridwar uttrakhand
Hardwar
UTTARANCHAL
249405
India |
| Phone |
9568242518 |
| Fax |
|
| Email |
pt3544080@gmail.com |
|
|
Source of Monetary or Material Support
|
| Patanjali bhartiya ayurvigyan evam anusandhan sansthan |
|
|
Primary Sponsor
|
| Name |
Patanjali bhartiya ayurvigyan evam anusandhan sansthan |
| Address |
OPD 5, Phase 1,Patanjali Bhartiya Ayurvigyan Evam Anusandhan Sansthan |
| 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 |
| Little Kumari |
Patanjali ayurveda hospital |
OPD 5,dept of kaumarbhritya phase 1,Patanjali ayurveda hospital
Hardwar
UTTARANCHAL |
7351637390
littlechaudhary06@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethical committee,patanjali bhartiya ayurvigyan evam anusandhan sansthan |
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: Shunthi yog, Reference: Chakradutt chapter 6, Route: Oral, Dosage Form: Avleha/Leha/Paka/Raskriya, Dose: 3(g), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 30 Days, anupAna/sahapAna: No, Additional Information: -no | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Dadima yog, Reference: Chakradutt chapter 6, Route: Oral, Dosage Form: Avleha/Leha/Paka/Raskriya, Dose: 3(g), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 30 Days, anupAna/sahapAna: No, Additional Information: -no |
|
|
|
Inclusion Criteria
|
| Age From |
1.00 Year(s) |
| Age To |
16.00 Year(s) |
| Gender |
Both |
| Details |
1 Patients from 1 yrs to 16 yrs of age
2 Patient fulfilling Romes criteria and ayurvedic symptoms of vibandha |
|
| ExclusionCriteria |
| Details |
1 Patients having chronic constipation due to fistula, fissure, hemorrhoids and anorectal
disorders.
2 Patients with history of TB, PEM, IBS and IBD
3 Having chronic neurological disease and congenital disorders.
4 Patient / attendant not willing to give written consent. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Relief in the symptoms of vibandha
Improvement in diagnostic tool Rome3rd criteria |
First follow-up-7th day
Second follow-up-15th day
Third follow-up- 30 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Improvement in overall health and nutrition
Improvement in digestion |
30 days |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
27/09/2025 |
| 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="0"
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
|
This is open label, comparative clinical trial to evaluate the efficacy of Shunthi yog and Dadima yog in vibandha. A total number of 60 patients fulfilling the ROME’s criteria and ayurvedic symptoms will be randomly divided into 30 each. One group will be recieving shunthi yog and other will be recieving dadima yog for 30 days. The efficacy will be assessed based on subjective symptoms like kshudamandya,udar shool,mala vega,mala swaroop,aadhman,feeling of incomplete evacuation,painful defecation and GISS score.Follow up will be done on 7th,15th,30th day of study. The aim is to compare both regimens and provide a cost effective ,safe and efficient ayurvedic intervention for vibandha. |