| CTRI Number |
CTRI/2025/03/082760 [Registered on: 19/03/2025] Trial Registered Prospectively |
| Last Modified On: |
16/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Survey |
| Study Design |
Other |
|
Public Title of Study
|
RESEARCH TO EVALUATE THE CONDITION OF DIGESTIVE HEALTH, VITALITY, AND QUALITY OF LIFE AMONG INDIVIDUALS AFFECTED BY ENDOSULFAN |
|
Scientific Title of Study
|
An observational study to assess the status of Agni, Ojus and Quality of life among Endosulfan-affected individuals in Kayyur-Cheemeni panchayat |
| 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 Sajna Krishnan K |
| Designation |
PG SCHOLAR |
| Affiliation |
GOVERNMENT AYURVEDA COLLEGE KANNUR |
| Address |
DEPARTMENT OF KRIYASAREERA
GOVERNMENT AYURVEDA COLLEGE KANNUR
Kannur
KERALA
670503
India |
| Phone |
9496084232 |
| Fax |
|
| Email |
sajnakrishnank95@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Hakkeem Panthappulan |
| Designation |
Assistant Professor |
| Affiliation |
GOVERNMENT AYURVEDA COLLEGE KANNUR |
| Address |
Department of Kriyasareera Government Ayurveda College Kannur
Kannur
KERALA
670503
India |
| Phone |
9947853745 |
| Fax |
|
| Email |
hpanthappulan@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Hakkeem Panthappulan |
| Designation |
Assistant Professor |
| Affiliation |
GOVERNMENT AYURVEDA COLLEGE KANNUR |
| Address |
Department of Kriyasareera Government Ayurveda College Kannur
Kannur
KERALA
670503
India |
| Phone |
9947853745 |
| Fax |
|
| Email |
hpanthappulan@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Kriyasareera
Government Ayurveda College Kannur |
|
|
Primary Sponsor
|
| Name |
Dr Sajna Krishnan K |
| Address |
Department of Kriyasareera
Government Ayurveda College Kannur Kerala 670503 |
| Type of Sponsor |
Other [SELF SPONSORED] |
|
|
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 Sajna Krishnan K |
FAMILY HEALTH CENTRE, KAYYUR |
Out patient department
Kasaragod
KERALA |
9496084232
sajnakrishank95@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC GOVERNMENT AYURVEDA COLLEGE PARIYARAM |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:Q00-Q99||Congenital malformations, deformations and chromosomal abnormalities. Ayurveda Condition: DUSHIVISHOPADRAVAH, (2) ICD-10 Condition:M00-M99||Diseases of the musculoskeletal system and connective tissue. Ayurveda Condition: DUSHIVISHAH/KRUTRIMAVISHAH, (3) ICD-10 Condition:G00-G99||Diseases of the nervous system. Ayurveda Condition: DUSHIVISHOPADRAVAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details |
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
1 Those who are already diagnosed and registered as Endosulfan-affected individuals in the records of Family Health Centre, Kayyur-Cheemeni panchayat
2 Age group 20 to 50 years
3 Those who provide informed consent irrespective of gender & socioeconomic status to participate in the study
|
|
| ExclusionCriteria |
| Details |
1 Individuals in the terminal stage of illness among the Endosulfan-affected population
2 Mentally retarded individuals among the Endosulfan-affected population
|
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
STATUS OF AGNI
STATUS OF OJUS
STATUS OF QUALITY OF LIFE |
18 MONTHS |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Relatipon of Agni & Ojus with the Quality of life |
18 MONTHS |
|
|
Target Sample Size
|
Total Sample Size="35"
Sample Size from India="35"
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)
|
29/03/2025 |
| 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="0"
Months="2"
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
|
This study aims to evaluate the state of agni ojus and the quality of life of individuals affected by endosulfan in the Kayyur Cheemeni Panchayat, as well as to identify any differences in the status of agni and ojus concerning their quality of life. Understanding the status of agni in those impacted by endosulfan will be beneficial when formulating treatment strategies for them. Evaluating the state of ojus will aid in assessing the vitality and resilience levels in individuals affected by endosulfan. Analyzing the quality of life of these individuals will contribute to a better understanding of their overall health status. Gaining insight into the conditions of agni, ojus, and quality of life can offer valuable information and advantages for their overall well-being and healthcare management. |