| CTRI Number |
CTRI/2022/03/041191 [Registered on: 17/03/2022] Trial Registered Prospectively |
| Last Modified On: |
16/03/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Yoga & Naturopathy |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
comparing the effect of cold hip bath and hot hip bath on patients who are having difficulty in passing stool |
|
Scientific Title of Study
|
Comparative study of cold hip bath and hot hip bath on patients with constipation |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DR SARANYA V V |
| Designation |
POST GRADUATE STUDENT |
| Affiliation |
SDM college of naturopathy and yogic sciences |
| Address |
1st floor division of natural therapeutics SDM college of naturopathy and yogic sciences ujire Belthangady
Dakshina Kannada
KARNATAKA
574240
India |
| Phone |
8289822621 |
| Fax |
|
| Email |
saranyavv22081994@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR SUJATHA K J |
| Designation |
Professor and Dean |
| Affiliation |
SDM college of naturopathy and yogic sciences |
| Address |
1st floor division of natural therapeutics SDM college of naturopathy and yogic sciences ujire
Dakshina Kannada
KARNATAKA
574240
India |
| Phone |
7349424672 |
| Fax |
|
| Email |
drsujathadinesh2@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR SARANYA V V |
| Designation |
POST GRADUATE STUDENT |
| Affiliation |
SDM college of naturopathy and yogic sciences |
| Address |
1st floor division of natural therapeutics SDM college of naturopathy and yogic sciences Ujire belthangady
Dakshina Kannada
KARNATAKA
574240
India |
| Phone |
8289822621 |
| Fax |
|
| Email |
saranyavv22081994@gmail.com |
|
|
Source of Monetary or Material Support
|
| SDM yoga and nature cure hospital shanthivana Dharmasthala 574216 Dakshina Kannada district Karnataka south india shanthivana@shridharmasthala.org |
|
|
Primary Sponsor
|
| Name |
DR SARANYA V V |
| Address |
SDM yoga and nature hospital shanthivana Dharmasthala |
| 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 SARANYA V V |
SDM nature cure hospital |
Department of research anveshana shanthivana dharmasthala 574216
Dakshina Kannada
KARNATAKA |
8289822621
saranyavv22081994@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SRI DHARMASTHALA MANJUNATHESHWARA COLLEGE OF NATUROPATHY AND YOGIC SCIENCES |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K638||Other specified diseases of intestine, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
cold hip bath |
cold hip bath will be given for 10 minutes on daily basis for 8 days continuously |
| Comparator Agent |
hot hip bath |
hot hip bath will be given for 1o minutes on daily basis for 8 days continuously |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
functional constipation meeting the Rome 3 criteria of functional bowel disorders |
|
| ExclusionCriteria |
| Details |
Patients with IBS
Fissures and Fistula
Haemorrhoids
Hernia
Patients sufferings with IHD
liver and lung diseases
parkinsonism
Analgesics
opioid use in last week
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| electrogastrogram |
Baseline and 8 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
constipation assessment scale
constipation scoring system
patient assessment of constipation quality of life
|
Baseline and 8 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
|
N/A |
|
Date of First Enrollment (India)
|
25/03/2022 |
| 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="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
comparitive study of cold hip bath and hot hip bath on patients with constipation
A
total of 60 subjects will be recruited based on inclusion and
exclusion criteria the study subjects will be allocated randomly into
two groups by using computer generated randomisation table Group 1
subjects will be given cold hip bath for 10 minutes daily for 8 days
Group 2 subjects will be given hot hip bath for 10 minutes daily for 8
days electrogastrogram and appropriate questionnaires will be assessed
from all subjects at the baseline and after 8 days of treatment
results will be analysed and published
|