| CTRI Number |
CTRI/2025/08/093372 [Registered on: 21/08/2025] Trial Registered Prospectively |
| Last Modified On: |
21/08/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Yoga & Naturopathy |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Effect of mud pack to the abdomen on stomach movements in patients with indigestion. |
|
Scientific Title of Study
|
The effect of mud pack to the abdomen on gastric motility in patients with dyspepsia - A randomized 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 |
Arunthathi .R |
| Designation |
Assistant medical officer/ lecturer grade 2 |
| Affiliation |
Government yoga and naturopathy medical college and hospital |
| Address |
No:1, PG Block, 2nd floor, Department of Naturopathy, Government yoga and naturopathy medical college and hospital, Arumbakkam, Chennai 600 106.
Chennai
TAMIL NADU
600106
India |
| Phone |
09976768329 |
| Fax |
|
| Email |
star.naturo@gamil.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Arunthathi R |
| Designation |
Assistant medical officer/ lecturer grade 2 |
| Affiliation |
Government yoga and naturopathy medical college and hospital |
| Address |
Government yoga and naturopathy medical college and hospital, post graduate block, Arumbakkam, Chennai 600 106.
TAMIL NADU
600106
India |
| Phone |
09976768329 |
| Fax |
|
| Email |
star.naturo@gamil.com |
|
Details of Contact Person
Public Query
|
| Name |
Arunthathi R |
| Designation |
Assistant medical officer/ lecturer grade 2 |
| Affiliation |
Government yoga and naturopathy medical college and hospital |
| Address |
No:1, Department of naturopathy, PG block, second floor, Government yoga and naturopathy medical college and hospital, Arumbakkam, Chennai 600 106.
TAMIL NADU
600106
India |
| Phone |
09976768329 |
| Fax |
|
| Email |
star.naturo@gamil.com |
|
|
Source of Monetary or Material Support
|
| Government yoga and naturopathy medical college and hospital, Arumbakkam, Chennai 600106. |
|
|
Primary Sponsor
|
| Name |
Government yoga and naturopathy medical college and hospital |
| Address |
Government yoga and naturopathy medical college and hospital, Arumbakkam, Chennai 600106. |
| Type of Sponsor |
Government medical college |
|
|
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 |
| Arunthathi R |
Government yoga and naturopathy medical college and hospital |
No:1, Department of naturopathy, PG block, second floor, Government yoga and naturopathy medical college and hospital, Arumbakkam, Chennai 600106.
Chennai
TAMIL NADU |
09976768329
star.naturo@gamil.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Government yoga and naturopathy medical college and hospital, Chennai Institutional ethics committe |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K30||Functional dyspepsia, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Mud pack to the abdomen (20 minutes) |
Participants in the study will undergo mud pack therapy, entailing the application of mud packs to the abdominal area while in a supine position for 20 minutes on an empty stomach in the morning which will be followed by a standard water load [150ml ingestion]. This treatment protocol will extend for 14 days. The methodology for administering the mud pack involves the placement of mud onto a sterile cotton cloth. The dimensions of the cloth designated for the abdominal mud pack measure approximately 23 cm in length, 16 cm in width, and 2 cm in thickness. The size of the cloth is subject to adjustment based on the body mass of the individual participant. |
| Comparator Agent |
Supine rest |
Participants will be permitted to take conventional medications. The intervention period will extend for 14 days. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1) Age between 18 to 60 years
2) Both gender (male and female)
3) Participants who are willing to give their consent
4) Participants with dyspeptic symptom of not less than 3months
|
|
| ExclusionCriteria |
| Details |
1) Patients already on drugs affecting Gastrointestinal motility, like prokinetics, and antipsychotics.
2) Patients with a past history of abdominal surgery.
3) Mental illness
4) Women during menstruation and pregnancy |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Gastric myoelectrical activity will be measured by using an electrogastrogram (MP160 BIOPAC system manufactured in the United States) on the 1st and 14th day of intervention. On Day 1, Pre, post and follow-up assessments will be taken before, immediately after and 30 minutes after the intervention to find the immediate effect. On day 14 post assessments will be performed to find the short-term effect. |
Assessments will be conducted on Day 1 before the intervention and 20 minutes after it, following the intake of 150 ml of water. A post-assessment will then be carried out 20 minutes after the water load. On Day 14, a post-assessment will be conducted 20 minutes after the intervention and water load. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Functional dyspepsia symptom diary |
Assessments will be taken on day 1 and day 14. |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
01/09/2025 |
| 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="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
|
A randomized controlled trial will be adopted for this study. 100 participants will be recruited from Government yoga and naturopathy medical college and hospital and will be randomized into two groups of 50 in each group namely study and control group. After basline asssessment of outcome variables, both the groups will undergo their respective interventions, and assessments will be taken immediately after the intervention and 20 minutes after 150 ml of water load. After 14 days, post assessment will be taken immediately after the intervention and 20 minutes after the 150 ml of water load. The study group will receive mud pack to abdomen and the control group will be advised to take supine rest for 20 minutes. The primary outcome variables will be gastric myoelectrical activity measured using electrogastrogram. The secondary outcome variable will be dyspepsia symptom diary. The values are collected basline, immediately after the 1st intervention, and 20 minutes after the 150 ml of water load, After 14 days of intervention, asessment will be taken immediately after the intervention and 20 minutes after the 150 ml of water load. It will be analysed using appropritae statistical methods. |