| CTRI Number |
CTRI/2025/12/098445 [Registered on: 04/12/2025] Trial Registered Prospectively |
| Last Modified On: |
03/12/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Yoga & Naturopathy |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Cold compress on constipation |
|
Scientific Title of Study
|
Evaluating the frequency of bowel movements in patients with constipation after implementation of compress for one month: A Pre- post inteventional study |
| 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 Jyoti Madhur |
| Designation |
Lecturer |
| Affiliation |
Maharishi Aurobindo Subharti College & Hospital of Naturopathy & Yogic Sciences, |
| Address |
Room no. 1, Naturopathy & Yoga, Swami Vivekanand Subharti University, Meerut
Meerut
UTTAR PRADESH
250005
India |
| Phone |
9758497123 |
| Fax |
|
| Email |
jyotimadhur05@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Jyoti Madhur |
| Designation |
Lecturer |
| Affiliation |
Maharishi Aurobindo Subharti College & Hospital of Naturopathy & Yogic Sciences, |
| Address |
Room no. 1, Naturopathy & Yoga, Swami Vivekanand Subharti University, Meerut
Meerut
UTTAR PRADESH
250005
India |
| Phone |
9758497123 |
| Fax |
|
| Email |
jyotimadhur05@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Jyoti Madhur |
| Designation |
Lecturer |
| Affiliation |
Maharishi Aurobindo Subharti College & Hospital of Naturopathy & Yogic Sciences, |
| Address |
Room no. 1, Naturopathy & Yoga, Swami Vivekanand Subharti University, Meerut
Meerut
UTTAR PRADESH
250005
India |
| Phone |
9758497123 |
| Fax |
|
| Email |
jyotimadhur05@gmail.com |
|
|
Source of Monetary or Material Support
|
| MASCHNYS, Swami Vivekanand Subharti University, Uttar Pradesh (Pin. 250005), India |
|
|
Primary Sponsor
|
| Name |
Dr Jyoti Madhur |
| Address |
Swami Vivekanand Subharti University, Meerut, Uttar Pradesh (Pin: 250005), India |
| Type of Sponsor |
Other [Self] |
|
|
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 Jyoti Madhur |
Chatrapati Shivaji Subharti hospital |
Naturopathy & Yoga OPD, Chatrapati Shivaji Subharti hospital, SVSU, Meerut, Uttar Pradesh, 250005 (INDIA)
Meerut
UTTAR PRADESH |
9758497123
jyotimadhur05@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| University Ethics Committee (Medical)) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K590||Constipation, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Cold Abdominal Compress |
The water temperature is 55° —70° C. A cotton cloth is then dipped and squeezed. It is applied over the abdomen for 3 to 30 seconds.
Total Duration: 2 times for 30 days
|
| Comparator Agent |
NA |
NA |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Inability to pass faces, smoothly or regularly
Hard stools or obstruction to its passage
Unproductive urges or feelings of incomplete evacuation
|
|
| ExclusionCriteria |
| Details |
Pregnant & Lactating Females.
They have any other co-morbid disorders with it.
Post-operative condition.
Subjects with less than 2 weeks symptoms.
Taking any other treatments or medicines.
|
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Ability to pass feces, smoothly or regularly
Easy to pass hard stools
Feeling of Complete evacuation |
at baseline and 4 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Wexner score for constipation |
at baseline & 4 weeks |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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)
|
15/12/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
15/12/2025 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="0"
Days="30" |
|
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
|
Defecation is an important
daily activity with important psychological and social significance for humans.
Constipation is infrequent bowel movements or difficult passage of stools that
persists for several days or weeks. It is an obstruction of the excretory
process and affects 12- 19 % of the general adult population, making it a
family issue. Hydrotherapy is an effective treatment for constipation.
This study explores the
efficacy of cold compress on constipation. Patients who come to the Maharishi Aurobindo Subharti College and
Hospital of Naturopathy & Yogic Sciences OPD will be diagnosed for
constipation and cold compress will be given in the prescribed format. Patient self-report about their
symptoms will be screened for the study. COLD COMPRESS: The water temperature is 55° - 70° C.
A cotton cloth is then dipped and squeezed. It is applied over the abdomen for
3 to 30 seconds. The compress should always cover an area
larger than the part to be influenced.
|