CTRI Number |
CTRI/2025/06/088991 [Registered on: 17/06/2025] Trial Registered Prospectively |
Last Modified On: |
17/06/2025 |
Post Graduate Thesis |
No |
Type of Trial |
Observational |
Type of Study
|
Follow Up Study |
Study Design |
Other |
Public Title of Study
|
Identifying diseases caused by weather changes in rural areas and exploring the development of latest techniques of prevention and awareness at very low cost through naturopathy after primary treatment through allopathy. |
Scientific Title of Study
|
Assessing Climate-Related Health Risks: A Study on Diseases Affected by Weather Changes in Rural Populations and Cost-Effective Naturopathic Interventions Following Allopathic Treatment |
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 Mulayam Singh |
Designation |
Researcher |
Affiliation |
Sir L.S.K. Group of Education & Research Institutions |
Address |
BL-158/635,
Hind Puram Colony, Near B.P. Gurukul Academy, Mainpuri-205001 (Uttar Pradesh) India Room No. 4 (Research Section)
Sir L.S.K. Group Compound,
BL-158/635,
Hind Puram Colony, Near B.P. Gurukul Academy, Mainpuri-205001(Uttar Pradesh) India Mainpuri UTTAR PRADESH 205001 India |
Phone |
6393372879 |
Fax |
|
Email |
mulayam099@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
Er Rajjan Babu |
Designation |
Manager |
Affiliation |
Sir L.S.K. Group of Education & Research Institutions |
Address |
BL-158/635,
Hind Puram Colony, Near B.P. Gurukul Academy, Mainpuri-205001 (Uttar Pradesh) India
Room No. 1 (Admin Section)
Sir L.S.K. Group Compound,
BL-158/635,
Hind Puram Colony, Near B.P. Gurukul Academy, Mainpuri-205001(Uttar Pradesh) India
Mainpuri UTTAR PRADESH 205001 India |
Phone |
8445429838 |
Fax |
|
Email |
rajjan.ic.2008@gmail.com |
|
Details of Contact Person Public Query
|
Name |
Adv Rajesh Babu |
Designation |
Tresurer |
Affiliation |
Sir L.S.K. Group of Education & Research Institutions |
Address |
BL-158/635,
Hind Puram Colony, Near B.P. Gurukul Academy, Mainpuri-205001 (Uttar Pradesh) India
Room No. 1 (Admin Section “B.P. Gurukul Academy”)
Sir L.S.K. Group Compound,
BL-158/635,
Hind Puram Colony, Near B.P. Gurukul Academy, Mainpuri-205001(Uttar Pradesh) India
Mainpuri UTTAR PRADESH 205001 India |
Phone |
9917990075 |
Fax |
|
Email |
rajeshbca68@gmail.com |
|
Source of Monetary or Material Support
|
|
Primary Sponsor
|
Name |
Sir LSK Group of Education Research Institutions |
Address |
BL-158/635,
Hind Puram Colony, Near B.P. Gurukul Academy, Mainpuri-205001 (Uttar Pradesh) India |
Type of Sponsor |
Research institution |
|
Details of Secondary Sponsor
|
|
Countries of Recruitment
|
India |
Sites of Study
|
No of Sites = 5 |
Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
Dr Mulayam SIngh |
Different CHC and PHC of Mainpuri District |
Mainpuri-205001(Uttar Pradesh) India Mainpuri UTTAR PRADESH |
6393372879
mulayam099@gmail.com |
Dr Mulayam Singh |
Health camps held in villages across all 9 blocks of Mainpuri district by the institution |
Mainpuri-205001(Uttar Pradesh) India Mainpuri UTTAR PRADESH |
6393372879
mulayam099@gmail.com |
Dr Mulayam Singh |
L.S.K. Research Center |
Room No. 1,
Sir L.S.K. Group Compound,
Hind Puram COlony, Mainpuri-205001 (Uttar Pradesh) India Mainpuri UTTAR PRADESH |
6393372879
mulayam099@gmail.com |
Dr Mulayam Singh |
Life Care Medical Store |
In front of Shiv Palace Marriage Hall, Ramaihar, Kurawali Road, Mainpuri - 205001 (Uttar Pradesh) India Mainpuri UTTAR PRADESH |
6393372879
mulayam099@gmail.com |
Dr Mulayam SIngh |
Maharaja Tej Singh (Government) District Hospital |
Mainpuri-205001(Uttar Pradesh) India Mainpuri UTTAR PRADESH |
6393372879
mulayam099@gmail.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 2 |
Name of Committee |
Approval Status |
Sir L.S.K. Group of Education and Research Institutions |
Approved |
Sir L.S.K. Group of Education and Research Institutions |
Approved |
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
(1) ICD-10 Condition: R651||Systemic inflammatory response syndrome (SIRS) of non-infectious origin, |
|
Intervention / Comparator Agent
|
Type |
Name |
Details |
Intervention |
Nil |
Nil |
|
Inclusion Criteria
|
Age From |
3.00 Year(s) |
Age To |
80.00 Year(s) |
Gender |
Both |
Details |
3 year to 80 years Male and Female |
|
ExclusionCriteria |
Details |
3 year to 80 years Male and Female |
|
Method of Generating Random Sequence
|
Not Applicable |
Method of Concealment
|
Not Applicable |
Blinding/Masking
|
Not Applicable |
Primary Outcome
|
Outcome |
TimePoints |
Disease recurrence within 6 months post-treatment (case vs. control), assessed by clinical evaluation and patient report. |
24 weeks |
|
Secondary Outcome
|
Outcome |
TimePoints |
- Incidence of new weather-related illnesses during follow-up.
- Hospital readmission rates within 12 months.
- Quality of Life (QoL) assessed by WHOQOL-BREF at baseline, 6 months, 12 months.
- Health Awareness (KAP) score changes from baseline to 12 months.
- Average monthly healthcare expenditure (allopathic + naturopathy costs).
- Adverse events associated with natal interventions.
|
24 weeks
48 weeks |
|
Target Sample Size
|
Total Sample Size="5000" Sample Size from India="5000"
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)
|
01/07/2025 |
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) |
Open to Recruitment |
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
|
Research Proposal on Identifying Diseases Caused by Weather Changes in Rural Areas and Exploring Low-Cost Naturopathy Techniques for Prevention and AwarenessIntroductionBackground of the Study Naturopathy has gained attention as a potential approach to address health issues related to environmental factors, particularly in rural regions where access to conventional healthcare may be limited.Significance of the ResearchAs climate change continues to alter weather patterns, the health implications for rural populations become increasingly pronounced, necessitating innovative preventative strategies. The integration of low-cost naturopathy techniques, such as herbal remedies and dietary adjustments, may not only enhance resilience against weather-induced ailments but also foster a deeper awareness of the interconnectedness between environment and health. For instance, studies indicate that individuals in rural areas often turn to complementary and alternative medicine (CAM) due to limited access to conventional healthcare, highlighting an opportunity to leverage these practices for greater health equity and disease prevention in vulnerable communities . Moreover, understanding how specific weather changes correlate with the incidence of diseases can empower local populations to adopt proactive health measures, thereby mitigating the adverse effects of climatic shifts . Research QuestionsFurthermore, the increasing frequency and severity of climate-related events, such as droughts and floods, can exacerbate health disparities in rural areas, highlighting the urgent need for targeted interventions. For instance, the World Health Organization has identified climate change as a significant health threat, with implications ranging from increased respiratory diseases due to poor air quality to heightened risks of vector-borne illnesses as ecosystems shift . By employing a community-centric approach that incorporates local knowledge and practices, rural populations can develop tailored preventative measures that not only address immediate health concerns but also promote long-term sustainability and resilience. This shift towards a more integrated health model could empower individuals to take charge of their well-being while fostering a collective response to the challenges posed by climate change. Such strategies may include workshops on herbal medicine, nutrition education, and the establishment of local support networks, thereby reinforcing the symbiotic relationship between environmental stewardship and health promotion. Literature ReviewIn addition to fostering local practices, it is essential to examine how environmental education (EE) can complement naturopathy initiatives in rural settings, enhancing community resilience against climate-related health issues. By integrating EE into the community framework, individuals can gain a deeper understanding of sustainable practices, such as organic farming and waste reduction, which directly impact health outcomes and environmental quality. For example, research indicates that EE programs not only promote physical activity but also improve dietary choices, thereby reducing the risk of chronic diseases associated with poor nutrition and environmental factors . Furthermore, empowering communities through education can lead to greater advocacy for health-promoting policies, encouraging a holistic approach that addresses both individual and collective health needs in the face of climate change. This synergy between naturopathy and environmental education could ultimately create a more informed and proactive populace, capable of navigating the complexities of health in an evolving climate landscape. This research aims to explore the intersection of naturopathy and environmental education, fostering resilience in rural communities facing climate-related health challenges. |