| CTRI Number |
CTRI/2025/03/082268 [Registered on: 13/03/2025] Trial Registered Prospectively |
| Last Modified On: |
12/03/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Process of Care Changes |
| Study Design |
Cluster Randomized Trial |
|
Public Title of Study
|
A study to compare efficacy of common salt application versus traditional medical treatment in scorpion bite reaction. |
|
Scientific Title of Study
|
Effects of local application of common salt on scorpion bite reaction among clients in selected hospitals and selected community in West Bengal. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
SOMA PATRA |
| Designation |
Clinical Instructor |
| Affiliation |
Govt. College of Nursing ID & BG Hospital Campus |
| Address |
Govt. College of Nursing ID & BG Hospital Campus,
Nursing Department,
Skills lab (For In-service Education),
57, Beliaghata Main Road, Kolkata.
Kolkata
WEST BENGAL
700010
India |
| Phone |
8918047943 |
| Fax |
|
| Email |
somapatra32@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
SOMA PATRA |
| Designation |
Clinical Instructor |
| Affiliation |
Govt. College of Nursing ID & BG Hospital Campus |
| Address |
Govt. College of Nursing ID & BG Hospital Campus,
Nursing Department,
Skills lab (For In-service Education),
57, Beliaghata Main Road, Kolkata.
Kolkata
WEST BENGAL
700010
India |
| Phone |
8918047943 |
| Fax |
|
| Email |
somapatra32@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
SOMA PATRA |
| Designation |
Clinical Instructor |
| Affiliation |
Govt. College of Nursing ID & BG Hospital Campus |
| Address |
Govt. College of Nursing ID & BG Hospital Campus,
Nursing Department,
Skills lab (For In-service Education),
57, Beliaghata Main Road, Kolkata.
Kolkata
WEST BENGAL
700010
India |
| Phone |
8918047943 |
| Fax |
|
| Email |
somapatra32@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Amta Superspeciality Hospital, Amta I Block, Howrah, West Bengal |
| Ashoknagar State General Hospital, North 24 parganas, West Bengal |
| B.B.Dhar rural Hospital, Amta II Block , Howrah, West Bengal |
| Barasat Govt. MCH, banamalipur, Barasat, North 24 Parganas, West Bengal |
| Bhatpara State General Hospital, North 24 parganas, West Bengal |
| Habra State General Hospital, North 24 Parganas, West Bengal |
| Naihati State General Hospital, North 24 parganas, West Bengal |
| Nanna BPHC, North 24 parganas, West Bengal |
| SaltLake Subdivision Hospital, 24, Salt Lake city, Kolkata, West Bengal |
| Sri Balaram Seva Mandir State General Hospital, North 24 parganas, West Bengal |
|
|
Primary Sponsor
|
| Name |
Soma Patra |
| Address |
Govt. College of Nursing, ID & BG Hospital Campus, 57, Beliaghata Main Road, Kolkata 700010 |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Mahua Debnath |
Nursing Training School, Barasat Govt. Medical College and Hospital, 80 Jessore Road, Banamalipur, Barasat, West Bengal, 700124 |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 10 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Ms Soma Patra |
Amta Superspeciality Hospital |
Village Amta , Pin 711401
Haora
WEST BENGAL |
8918047943
somapatra32@yahoo.com |
| Ms Soma Patra |
Ashoknagar State General Hospital |
Ashoknagar, Ashoknagar Kalyangarh, North 24 parganas, pincode 743222
North Twentyfour Parganas
WEST BENGAL |
8918047943
somapatra32@yahoo.com |
| Ms Soma Patra |
B.B.Dhar Rural Hospital |
Amaragori, Joypur , Pincode 711401
Haora
WEST BENGAL |
08918047943
somapatra32@yahoo.com |
| Ms Soma Patra |
Barasat Govt. Medical College and Hospital |
80 Jessore Road, Banamalipur, Barasat, Pincode 700124
North Twentyfour Parganas
WEST BENGAL |
8918047943
somapatra32@yahoo.com |
| Ms Soma Patra |
Bhatpara State General Hospital |
Golghor,Jagadal, Pincode 743125
North Twentyfour Parganas
WEST BENGAL |
8918047943
somapatra32@yahoo.com |
| Ms Soma Patra |
Habra State General Hospital |
Habra, Pincode 743263
North Twentyfour Parganas
WEST BENGAL |
8918047943
somapatra32@yahoo.com |
| Ms Soma Patra |
Naihati State General Hospital |
Naihati, Pincode 743165
North Twentyfour Parganas
WEST BENGAL |
8918047943
somapatra32@yahoo.com |
| Ms Soma Patra |
Nanna Block Primary Health Centre |
Nanna, Kanchrapara Loco, Halisahar, Pincode 743135
North Twentyfour Parganas
WEST BENGAL |
8918047943
somapatra32@yahoo.com |
| Ms Soma Patra |
Salt Lake Sub Division Hospital |
Dd 36, Sector 1, Salt Lake City, Sector 1, Pincode 700064
Kolkata
WEST BENGAL |
8918047943
somapatra32@yahoo.com |
| Ms Soma Patra |
Sri Balaram Seva Mandir State General Hospital |
MS Mukherjee Road, Kalyan Nagar, Kulinpara, Pincode 700116
North Twentyfour Parganas
WEST BENGAL |
8918047943
somapatra32@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| All Settings |
No Objection Certificate |
| IEC- IDBGH |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: T51-T65||Toxic effects of substances chiefly nonmedicinal as to source, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Local application of common salt |
The intervention group consisted of 05 hospitals in rural areas after randomly allocated to either the intervention group or the control group using a computer-generated randomization sequence, which will received tetanus prophylaxis and salt therapy by nurses in selected hospitals.
Implemental strategy
Data collection team: 100 staff nurses of various setting in rural hospitals will be trained about assessing pain by use of universal pain assessment tool and applying salt therapy to the participants. These Nurses will help in collecting data.
Plan for data collection procedure
Information regarding research study will be explained to the participants.
Before collection of the data, informed consent will be obtained from participants.
Participants will be informed if they want to withdraw themselves from the investigation they can terminate any phase of investigation.
Coding system will be done to maintain confidentially.
Data will be collected by using of standardized Numerical rating pain scale(WHO) for pain score. Observation and measurement for redness and swelling will be done by slandered scale, followed by administration of salt therapy will be given in experimental group on a time of attain and post pain score measurement will be conducted on 30 minutes interval for 3 times.
Administration of salt therapy
Clean the indurations area with a wet cotton ( with water) or clean cloth piece.
Apply 0.04gm salt/cm2
Applying for 10 mins.
Dry common table salt massage with circular movement up to the solid salt particle become dissolve.
Measure pain and other local inflammation (redness and swelling) after half an hour interval for 3 times.
Measure pain and other local inflammation (redness and swelling ) local inflammation after six hour interval.
Repetition of salt therapy Repeat salt therapy in the pain recurrence after subside of pain in 1st intervention.
Rescue therapy Standard medical treatment in case of not reliving pain after 30 min. |
| Comparator Agent |
Standard Medical treatment |
The control group consisted of 05 hospitals at rural areas after randomly allocated to either the intervention group or the control group using a computer-generated randomization sequence, which continued with their standard medical treatment with antihistamine, corticosteroid, analgesics or local blocking by lignocaine as per prescription of physicians. Reduction of pain and others local inflammation will be measured and recorded after half an hour interval for 3 times and after six hours interval also. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Patients who will attend within 4 hrs. of bite.
Patients with hemodynamically stable.
|
|
| ExclusionCriteria |
| Details |
Patient who are not sure about biting.
Patients of unknown bite.
Patients who use any therapy used before to reduce pain.
Patients with anaphylaxis shock.
Patients with severe urticaria. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Reduction in Pain Intensity The study will measure the reduction in pain intensity at the bite site, as assessed by the WHO numerical pain scale at 30 minutes, 1 hour, and 1.30 hours and 6 hours after the application of salt.
2. Decrease in Swelling and Inflammation
The study will evaluate the decrease in swelling and inflammation at the bite site, as measured by the circumference of the affected limb, at 30 minutes, 1 hour, and 1.30 hours and 6 hours after the application of salt. |
Base line, pre intervention (o1)
30 min. post intervention (o2)
60 min. post intervention (o3)
90 min. post intervention (o4)
06 hrs. post intervention (o5) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Time to Onset of Pain Relief
The study will record the time taken for the patient to experience pain relief after the application of salt.
2. Duration of Pain Relief
The study will measure the duration of pain relief after the application of salt. |
24hours following scorpion bite |
|
|
Target Sample Size
|
Total Sample Size="500"
Sample Size from India="500"
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)
|
24/03/2025 |
| 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="3"
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
|
This study is a cluster randomized control multicentre trial comparison efficacy of local application of common salt with standard medical treatment following 500 scorpion bite patients in 10 hospitals of rural areas in West Bengal , India. The primary outcome measure will be reduced the pain intensity , local swelling and local redness at 30 min, 60 min, 90 min and 06 hours of post intervention following baseline.The secondary outcome measures will consider the time to onset of pain relief and duration of pain relief. |