NIH

Annual Reports

6. ANNUAL REPORTS & TIMELINE:

S.No.

Objective Name/Deliverable

1st Year

2nd Year

3rd Year

Laboratory infrastructure setup & In-Silico studies

1.1	Infrastructure setup (Preclinical and Clinical)	Laboratory setup procurement of equipment and Consumables/medicine/ reagent	Data Acquisition & Analysis Software	completed
1.2	regulatory and ethical approval	RAC/IEC Approval & AEC, if applicable	Revision, if needed	completed

2. In-Silico analysis of 10 homoeopathic drugs

2.1	Chemical profiling (Preclinical)	GC-MS/LC-MS analysis of 10 medicines	Analysis of result & repetition of analysis, if required	completed
2.2	In-silico studies (Preclinical)	Molecular docking, network pharmacology	Analysis of result & repetition required	completed

3. In-vitro and In-vivo analysis of 10 homoeopathic drugs

3.1

In-vitro & in-vivo studies (Preclinical)

Preparation of laboratory and Anti-oxidant assay, Anti-inflammatory Assay,

characterization profile Animal or cell lines study

Animal studies Report analysis

4. The comparative, prospective, randomized, open-label, two-arm, parallel-group controlled clinical trial preparation and patient enrolment process initiation

4.1	Preparation of Monograph/Outreach materials (Clinical)	Preparation of Monograph	Finalization of material documents	Outreach activities
4.2	Staff training (Preclinical and Clinical)	Recruitment of manpower	Preparation of standard operative procedure (SOPs) and training, lab training (Hand wash, BMW, etc), Assignment of works	Collection and storage of all documented materials in MRD room

5. Implementation of comparative, prospective, randomized, open-label, two-arm, parallel-group controlled clinical trial

5.1	Clinical protocol preparation and finalization (Clinical)	Finalization of Case Report form (CRF), Informed Consent Forms (ICF), CTRI Registration, Investigator’s Brochure (IB)	Implementation of SOPs, training	Collection and storage of documents
5.2	Patient recruitment (Clinical)	Begin enrollment for clinical trials after CTRI approval, if required	Enrolment of patients	Analysis of documents

6. Interim data Analysis

6.1

Interim Analysis (Preclinical and Clinical)

In-silico study

Analysis of In-silico, In-Vitro & In-Vivo Study result for safety and efficacy analysis

Repetition of analysis, if required

7. Synthesis and final data preparation

7.1	Final clinical trial data (Preclinical and Clinical)	Procurement of data analysis software	Handling dropout and missing data	Collection of complete data for data analysis include follow-up and lab analysis
7.2	Report preparation for data (Preclinical and Clinical)		Interim analysis	Data analysis of 5 metabolic disorders along with result and discussion

8. Publication

8.1

Publications (Preclinical and Clinical)

Preparation of Journal selection and APC

Writing result, discussion and conclusion of minimum 2 paper

Publication - two research paper

9. Workshop/hands on training/CME

9.1

Workshop/CME /training

One day workshop about brainstorming session on Identification and collection of documents required for further study

One day workshop about brainstorming session on preparation of document, SoP for further study

3 days In-House training about metabolic disorders management

10. Limitation and recommendation

10.1

Final review and recommendations for future research

Identification of limitation of In-silico studies

Preparation of recommendation, protocol preparation, implementation for future research and use of AL/ML learning.

Summary and interpretation of findings to AYUSH faculty, Interactive talks, Skill practical training and Feedback collection

11. Prepare and submit policy briefs to Ministry of Ayush

राष्ट्रीय होम्योपैथी संस्थान

NATIONAL INSTITUTE OF HOMOEOPATHY

Annual Reports