| CTRI Number |
CTRI/2025/09/095128 [Registered on: 19/09/2025] Trial Registered Prospectively |
| Last Modified On: |
08/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Ayurveda treatment for constipation in children |
|
Scientific Title of Study
|
Evaluation of comparative efficacy of Trivritadi syrup versus Shunthyadi syrup in the management of Vibandha (Constipation) in children: A Randomised Controlled 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 ANIRUDDHA SANTOSHRAO UNHALE |
| Designation |
PG Scholar |
| Affiliation |
Mahatma Gandhi Ayurved College, Hospital and Research Centre Salod(H) Wardha |
| Address |
Room No 41 Department of Kaumarbhritya Mahatma Gandhi Ayurved College Hospital and Research Centre Salod Hirapur Wardha
MAHARASHTRA 442001 India
Wardha
MAHARASHTRA
442001
India
Wardha
MAHARASHTRA
442001
India |
| Phone |
7743924763 |
| Fax |
|
| Email |
anipatil151@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR SONAM KANZODE |
| Designation |
Associate Professor |
| Affiliation |
Mahatma Gandhi Ayurved College, Hospital and Research Centre Salod(H) Wardha |
| Address |
Room No 41 Department of Kaumarbhritya Mahatma Gandhi Ayurved College Hospital and Research Centre Salod Hirapur Wardha
MAHARASHTRA 442001 India
Wardha
MAHARASHTRA
442001
India
Wardha
MAHARASHTRA
442001
India |
| Phone |
7387553665 |
| Fax |
|
| Email |
sonam.kaumarbhritya@dmiher.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
DR ANIRUDDHA SANTOSHRAO UNHALE |
| Designation |
PG Scholar |
| Affiliation |
Mahatma Gandhi Ayurved College, Hospital and Research Centre Salod(H) Wardha |
| Address |
Room No 41 Department of Kaumarbhritya Mahatma Gandhi Ayurved College Hospital and Research Centre Salod Hirapur Wardha
MAHARASHTRA 442001 India
Wardha
MAHARASHTRA
442001
India
Wardha
MAHARASHTRA
442001
India |
| Phone |
7743924763 |
| Fax |
|
| Email |
anipatil151@gmail.com |
|
|
Source of Monetary or Material Support
|
| Mahatma Gandhi Ayurveda college And Hospital Research center Salod (Hirapur) Wardha 442001 Maharashtra India |
|
|
Primary Sponsor
|
| Name |
Mahatma Gandhi Ayurveda College And Hospital Research Center |
| Address |
Mahatma Gandhi Ayurved College Hospital and Research Centre Salod(H) Wardha MAHARASHTRA 442001 India |
| 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 ANIRUDDHA SANTOSHRAO UNHALE |
Mahatma Gandhi Ayurveda College Hospital and Research Centre Hirapur Salod Wardha |
Room No 41, Department of Kaumarbhritya, Mahatma Gandhi Ayurved College, Hospital and Research Centre Salod(H) Wardha.
MAHARASHTRA 442001 India
Wardha
MAHARASHTRA
442001
India
Wardha
MAHARASHTRA |
7743924763
anipatil151@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Mahatma Gandhi Ayurved College Hospital and Research Centre Institutional Committee Salod(H) Wardha Maharashtra 442001 |
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 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Shunthyadi Syrup, Reference: Bhava Prakash Madhyam Khanda Chapter 1 , Route: Oral, Dosage Form: Sharkara/ Syrup, Dose: 7(ml), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 7 Days, anupAna/sahapAna: Yes(details: Koshna Jal), Additional Information: - | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Trivritadi Syrup, Reference: Sushrut Samhita Sutra Sthan Chapter 44 Verse 17, Route: Oral, Dosage Form: Sharkara/ Syrup, Dose: 7(ml), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 7 Days, anupAna/sahapAna: Yes(details: Koshna Jal), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
5.00 Year(s) |
| Age To |
15.00 Year(s) |
| Gender |
Both |
| Details |
Children whose parents are giving written consent for their child to participate in the study.
Patients from 5 years to 15 years of age suffering from vibandha irrespective of religion, race, gender, and socioeconomic condition.
Vibandha caused due to dosha and agni dushti or any other metabolic problems related to digestion like abdominal pain, distension, anorexia with a history of constipation in children.
Constipation grade between 2 to 3 on bristol stool scale. |
|
| ExclusionCriteria |
| Details |
Patients requiring surgical management will be excluded.
Patients suffering from any known acute or chronic medical and surgical illness or a congenital anomaly of the anus and rectum will be excluded.
Known cases of chrons disease, hirschsprungs disease, tb, hiv and malignancies will be excluded.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess the efficacy of Trivritadi syrup over Bristol stool scale in children having Vibandha (Constipation) |
7 Days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To assess the efficacy of Shunthyadi syrup over Bristol stool scale in children having Vibandha (Constipation) |
7th and 14th Day |
|
|
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 3/ Phase 4 |
|
Date of First Enrollment (India)
|
20/10/2025 |
| 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="2"
Months="0"
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
|
The volunteers will be informed about the study protocol. Willing participants will be randomly selected as per a computer-generated table. The clinical research format will be prepared and validated. Before the study, approval will be taken from IEC, MGACHRC, Salod (H) Wardha, and CTRI registration will be done. After selection, each participant will be tested individually and selected according to the selection criteria. They are divided into two groups. The trial is a Randomized Double Blind Equivalence Standard Control Clinical Trial. It will include a 7-day treatment period and a follow up period during treatment on the 3rd, 5th, and 7th day and after treatment on 8th and 14th day.
|