| CTRI Number |
CTRI/2025/12/098841 [Registered on: 10/12/2025] Trial Registered Prospectively |
| Last Modified On: |
04/12/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Effect of Gudapippali yoga in Constipation in children. |
|
Scientific Title of Study
|
A single arm clinical study to evaluate the efficacy of Gudapippali yoga in
Vibandha with special reference to functional constipation 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 |
Dr Aakash Kishor Patil |
| Designation |
1st year PG Kaumarbhritya |
| Affiliation |
Dr G D Pol Foundation YMT Ayurvedic medical college , Kharghar , Navi Mumbai |
| Address |
OPD no 18 and Room 207 , second floor ,Dr G D Pol Foundation YMT Ayurvedic medical college , Kharghar , Navi Mumbai ,Maharashtra ,India ,410210
Raigarh
MAHARASHTRA
410210
India |
| Phone |
7083015523 |
| Fax |
|
| Email |
patilaakash177@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sonia Sawant |
| Designation |
Associate Professor , Kaumarbhritya dept YMT College Kharghar |
| Affiliation |
Dr G D Pol Foundation YMT Ayurvedic medical college , Kharghar , Navi Mumbai |
| Address |
OPD no 18 and Room 207 , second floor ,Dr G D Pol Foundation YMT Ayurvedic medical college , Kharghar , Navi Mumbai ,Maharashtra ,India ,410210
Raigarh
MAHARASHTRA
410210
India |
| Phone |
9869262410 |
| Fax |
|
| Email |
drsoniasawant3@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sonia Sawant |
| Designation |
Associate Professor , Kaumarbhritya dept YMT College Kharghar |
| Affiliation |
Dr G D Pol Foundation YMT Ayurvedic medical college , Kharghar , Navi Mumbai |
| Address |
OPD no 18 and Room 207 , second floor ,Dr G D Pol Foundation YMT Ayurvedic medical college , Kharghar , Navi Mumbai ,Maharashtra ,India ,410210
Raigarh
MAHARASHTRA
410210
India |
| Phone |
9869262410 |
| Fax |
|
| Email |
drsoniasawant3@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr G D Pol Foundation YMT Ayurvedic medical college , Kharghar , Navi Mumbai ,Maharashtra ,India ,410210 |
|
|
Primary Sponsor
|
| Name |
Dr Aakash Patil |
| Address |
Dr G D Pol Foundation YMT Ayurvedic medical college , Kharghar , Navi Mumbai ,Maharashtra ,India ,410210 |
| Type of Sponsor |
Other [self] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Dr Sonia Sawant |
Dr G D Pol Foundation YMT Ayurvedic medical college , Kharghar , Navi Mumbai |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Aakash Kishor Patil |
Dr G D Pol Foundation YMT Ayurvedic medical college , Kharghar |
OPD no 18 and Room 207 , second floor ,Dr G D Pol Foundation YMT Ayurvedic medical college , Kharghar , Navi Mumbai ,Maharashtra ,India ,410210
Raigarh
MAHARASHTRA |
7083015523
patilaakash177@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee Dr G D Pol Foundation YMT Ayurvedic medical college and charitable hospital |
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: Gudapippali yoga, Reference: Chakradatta 6/14, Route: Oral, Dosage Form: Churna/ Powder, Dose: 0(mg), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 15 Days, anupAna/sahapAna: Yes(details: -Koshna jala), Additional Information: -Dose will be calculated by Clarks rule as per weight of child |
|
|
|
Inclusion Criteria
|
| Age From |
4.00 Year(s) |
| Age To |
16.00 Year(s) |
| Gender |
Both |
| Details |
1.Children age between 4 to 16 years.
2.Irrespective of age, sex, socioeconomic condition and religion.
3.Patients having symptoms of functional constipation as per diagnostic criteria.
4.Criteria specifically fulfilling Rome IV criteria for functional constipation Rome IV criteria more than or equal to 2 symptoms |
|
| ExclusionCriteria |
| Details |
Patients will be excluded if,
1. Patients having Organic Constipation or any abdominal obstructive pathologies which intervenes with treatment.
2. Patients suffering from any systemic diseases e.g. Hirschsprung’s disease,
Intussusception, Anorectal anomalies, Hypothyroidism, T.B, HIV etc.
3. Having psychosomatic disorders.
4. Patients having condition of acute abdominal pain, acute febrile illness
etc.
5. K/c/o IBS and prolapsed rectum. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
To assess the clinical efficacy of Gudapippali yoga in symptomatic
improvement as per ROME lV of vibandha in children.
|
15 Days intervention ,follow up on 3rd ,7nth ,15th ,30th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.To evaluate the tolerance and safety of gudapippali yoga in children.
2.To observe the impact of this approach on parental satisfaction and
quality of life. |
Assessment on 0th, 3rd, 7th,15th,30th day
|
|
|
Target Sample Size
|
Total Sample Size="48"
Sample Size from India="48"
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)
|
01/01/2026 |
| 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
|
In Ayurveda, the human body is believed to be composed of three main elements - Dosha, Dhatu, and Mala. The process of digestion and metabolism results in the manifestation of Mala, waste products such as Purisha and Mutra, from the consumed food and Dhatu. Functional constipation, which translates to obstruction or constipation, is a condition that can occur due to disturbances in the Purishavaha Srotas, particularly affecting the functioning of Apana Vayu in children. Children commonly experience functional constipation, which can be attributed to various factors such as dietary habits, lifestyle choices, reduced fiber and water intake, or habitual reasons. Functional Constipation is characterized by the passage of hard stools infrequently, with referring to a condition without an organic cause, often seen in children who withholds faeces to avoid painful defecation. Pippali churna and Gudachurna is known for its properties that aid in digestion, relieve constipation, and regulate Vata. This yoga has been selected for further study due to its potential effectiveness in managing functional constipation, making it a valuable and easily accessible option in the treatment of this common condition in children. The incidence rate of the functional constipation is 3 % .The sedentary lifestyle of many children, who prefer indoor activities like playing video games, using mobile phones, and engaging in computer games over outdoor games, has also contributed to the rise in functional constipation cases. Laxative abuse is a common cause of constipation, as it can lead to changes in intestinal function and electrolyte balance, potentially becoming habit-forming. Surprisingly, there has been no research conducted on functional constipation with Gudapippali Churna in the paediatric age group. This treatment, known for its digestive and purgative properties, has been chosen as the focus of the current study due to its availability, cost-effectiveness, and effectiveness in managing Vata-related disorders. |