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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  
NIL 
 
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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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 Awareness

Introduction

Background 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 Research

As 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 Questions

Furthermore, 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 Review

In 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.

 
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