Trial objectives and purpose

DOCUMENTATION, CLINICAL VALIDATION AND EXPLORING THE EFFICACY OF “NEERKURI AND NEIKURI ANALYSIS OF COVID 19 CASES - A COST EFFECTIVE SIDDHA DIAGNOSTIC METHOD” Phase-II Clinical Trials

Research methodology

Design of study;

The type of study is A Two arm randomized trial on efficacy of Siddha diagnostic method..

Trial study center:

The centre of study will be, Kokila Siddha Hospital and Research Centre (NABH Accredited), Kunnamanpatti Village, Karadikkal Post, Thirumangalam Taluk Madurai 625706

IEC clearance:

IEC of the organization is obtained on 22 April 2020

Sample size and period of study

Enrollment                                            : Not below 20 or the maximum cases in Six months

Study Start Date                                  : 10 June 2021

Study Completion Date                       : 09 December 2021

Final Completion Date                         : 01 January 2021  

(Final data completion date for outcome measure)

Screening of Patients for study

In the present study patients suffering from “COVID 19 will be taken for study. The Inclusion and exclusion will be made by regarding the state of morbidity in the wards to continue the trial till they discharged.

Whenever a patient is included in the study a consent form in his mother tongue detailing the procedures will be explained and details of the follow up visit will also be explained.

Criteria for Inclusion

The Inclusion criteria

Known case COVID 19

18-70 years

Male, Female and transgender

Criteria for Exclusion

DUB women, Scrotal, Vaginal multi tract Fistula, children below 3 years  

Criteria for withdrawal                                                                                                           

During the course of the trial, if any serious conditions develop (or) the prognosis is worst, bladder catheterization is provided, such subjects may be withdrawn from the trial.

Routine Examination and assessment ;

The complete History and symptoms of the patients will be recorded. The urine collected in the early morning from admission to discharge would be used for this study.  

Materials and Methods;

 The Neerkuri and Neikuri study of COVID 19 positive cases in Phase 2 clinical trial of minimum 20 confirmed patients, aged 18 years to 80 years

The Ethics committee of Kokila Siddha Hospital and Research Centre will follow the ethical issues. In the period between May 2020 to July. 2020, respondents who confirmed and admitted in the ward are taken for this study.

Statistical analysis

In this study we could analyse

Humor differentiation

Early detection of disease

Patterns in different stages

Prognosis in different stages

Gender and patterns

Symptoms and patterns

Morbidity and pattern

Physical nature of standard care

The proposal outcome would show light on siddha diagnostic method

1.Outcome

1(a) .Primary outcome measurement

Cost effective diagnostic method for COVID 19 cases 

Efficacy of Siddha Diagnostic tool Neerkuria nd Neikuri for COVID 19 cases

Patient name or UHID Number:

Age:

Sex:

Type of Sample: Urine

IEC No:

Consent Form no:

Research Period:

Place of Sample Collection:

Date of First Visit (Day -1):

Daily collection details

SCORING Response

      Scale. The patterns are incorporated with clinical findings and interpreted with COVID 19 symptoms

Success indicators;

Defined patterns or indication of same patterns or change in patterns in different stages

Direct access to source data/documents

We hereby agree that the investigator(s)/institution will permit trial-related monitoring, audits, institutional review board/independent ethics committee review, and regulatory inspection(s), by the Research Council/Department of AYUSH providing direct access to source data/documents wide various publications.

Quality control and quality assurance

The assessment, procedure, reference, PPD, ethics, bio medical waste management etc are assured services to maintain the quality and Hospital Infection Control measures.

Participant protections and ethics

            To protect human participants, the protocol was written according to general ethical guidelines, such as the Declaration of Helsinki and Good Clinical Practice and was approved by the institutional ethical committee of the organization. The study participant consent process includes information about potential risks, benefits, alternatives, and responsibilities during the trial. Before participants agree to participate in this trial, researchers will explain this information in detail in person.

Monetary benefits to the participants

The participants are informed about trial and their own pocket expenses will not be allowed. All expenses including urine analysis (Neerkuri and Neikuri) investigations and consumables would be borne by the research institution.

Monitoring of Study

Regular monitoring that will be clarified in a standard operating procedure will be conducted   to ensure good data quality. Monitors from IEC will evaluate whether the case report forms are properly written and whether the recruiting and treatment procedures are adequately performed according to the protocol. Investigators will be contacted to discuss whether it is necessary to revise the study protocol or inclusion criteria and other important issues.                            

Case Sheets will be prepared for each patient and retained with the PI for Five years

Conclusion

            Our policy on AYUSH stream is mainly highlighting the drugs, but a large research area on Siddha fundamentals and principles on ancient diagnostic methods. It is because of lack of acceptable evidence of practice and efficacy of Neerkuri and neikuri. Evidence should be generated by the performance of well designed studies with customized and self designed protocol. The current research work is designed to discuss the novel way for the early diagnosis of COVID 19 patients and developing an evidence base in Siddha diagnostic models, so as to enhance the acceptability of this method in Siddha system for future research.

            Our aim is to provide relief to the sufferings of the latest testing kits those the common man could not afford. Neerkuri and neikuri test at affordable cost and non invasive method help the professionals to select the appropriate testing method by validation..

We hope that we can achieve our aim – Popularization of Siddha testing methods with the guidance and support of CCRS , Chennai and the Ministry of AYUSH. New Delhi.

Thanking you,                                                                     Chairman and Principal Investigator