| CTRI Number |
CTRI/2024/09/074510 [Registered on: 27/09/2024] Trial Registered Prospectively |
| Last Modified On: |
13/09/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Yoga & Naturopathy |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Turmeric fumigation and jala neti treatment for common cold |
|
Scientific Title of Study
|
Combined effect of turmeric fumigation and jalaneti kriya in common cold among young adults 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 |
Dwithi K D |
| Designation |
UG scholar |
| Affiliation |
Alvas college of naturopathy and yogic sciences |
| Address |
Room No 7, Department of Yoga, Shobhavana campus, Mijar, Moodbidri.
Dakshina Kannada
KARNATAKA
574225
India |
| Phone |
7975915641 |
| Fax |
|
| Email |
dwithikd2@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Swathi K V |
| Designation |
Associate professor |
| Affiliation |
Alvas college of naturpathy and yogic sciences |
| Address |
Room No 7, Department of Yoga, Shobhavana campus, Mijar, Moodbidri.
Dakshina Kannada
KARNATAKA
574225
India |
| Phone |
9964743920 |
| Fax |
|
| Email |
drswathi806@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Anupritha |
| Designation |
Assistant professor |
| Affiliation |
Alvas college of naturopathy and yogic sciences |
| Address |
Room No 7, Department of Yoga, Shobhavana campus, Mijar, Moodbidri.
Dakshina Kannada
KARNATAKA
574225
India |
| Phone |
7019294074 |
| Fax |
|
| Email |
anuprithaashok@gmail.com |
|
|
Source of Monetary or Material Support
|
| Alvas college of naturopathy and yogic sciences tenkamijar shobhavana capmus mijar
moodbidre dakshina kannada karnataka 574225 |
|
|
Primary Sponsor
|
| Name |
Rajiv gandhi university of health sciences |
| Address |
12,30th cross rd opp. sagar hospsital,4th t tblock east pattabhirama
road jayanagar bengaluru karnataka 560041 |
| Type of Sponsor |
Other [Undergraduate research projects grant ] |
|
|
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 Swathi K V |
Alvas Anandamaya Arogyadhama hospital |
Room No 2, Department of Yoga Research, Shobhavana campus, Mijar, Moodbidri.574225
Dakshina Kannada
KARNATAKA |
9964743920
drswathi806@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethical committee of Human Sciences Of Alvas college Of Naturopathy and Yogic Sciences |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J00||Acute nasopharyngitis [common cold], |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Allopathic treatment |
No naturopathic intervention will be given. Patient will be asked to follow up their regular conventional medication and followed up for 7 days |
| Intervention |
Jala neti and turmeric fumigation |
patients will be given turmeric fumigation from dhoop and also jala neti kriya after an hour and will be followed up for 7 days |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
25.00 Year(s) |
| Gender |
Both |
| Details |
Acute onset common cold
Willing to participate in the study |
|
| ExclusionCriteria |
| Details |
COPDs ( chronic obstructive pulmonary disease )
DNS (deviated nasal septum)
Epistaxis
Fever above 102 |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Total leucocyte count Differential leucocyte count
Erythrocyte sedimentation rate |
baseline-pre intervention
post intervention- 7 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Total nasal symptom score |
baseline-pre assessment
post assessment -7 days |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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)
|
20/10/2024 |
| 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 Yet Recruiting |
| 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 common cold is a prevalent illness that has garnered attention from both medical professionals and the public due to its self-limiting nature and associated symptoms, such as headaches, sneezing, and rhinorrhea. Symptoms can last from two days to over fourteen days, with nasal discharge changing from watery to thicker and purulent over time . - While the common cold is generally not harmful, it can lead to significant health issues if followed by bacterial infections. Rhinovirus is responsible for a substantial percentage of these infections .
- The study will take place at Alva’s Anandamaya setup, where 30 participants will be screened based on specific inclusion and exclusion criteria. They will be randomly divided into two equal groups using a lottery method . - The first group will receive turmeric fumigation and Jala Neti, while the second group will undergo conventional allopathic therapy for 10 days. Pre and post assessments of symptoms and duration of illness will be recorded for both groups . |