Assessment and Effectiveness of Siddha Interventions in Menstrual Disorders among High school and college students in Greater Chennai Corporation of Tamil Nadu-2025 to 2027.

This study is a Ministry of AYUSH Govt. of India grant project under the scheme AYURSWASTHYA YOJANA  A Public Health Initiative.Study title is Assessment and Effectiveness of Siddha Intervention in Menstrual Disorders among High school and colleges students in Greater Chennai Corporation of Tamil Nadu 2025 to 2027. Aim and objectiveof the study is to estimate the proportion of menstrual disorders and document the effectiveness of Siddha interventions for menstrual disorders among Govt. school and college students and CHCs or DHs in GCC Tamil Nadu. Secondary objectives are to create  awareness about menstrual disorders and menstrual hygiene and promote Siddha diet and lifestyle for the prevention or management of menstrual disorders among students by conducting Siddha medical camps and public lectures and distributing pamphlets. To assess the changes in laboratory tests and USG studies the hormonal imbalance after intake of Siddha medicines in selected participants and observe and document the adverse reactions if any. Methodology of the study are Study design iscross sectional study design and pre and post evaluation design. Duration of the study is 3 years 2025 to 2027. Study participants are adolescent girls and younger women of age group 15 to 25 years. Sample sizeof the project is 1250 among them around 5 percentage students dropped out from school and colleges will be recruited from CHC or DH. Sampling method  is Block randomization for selection of schools and colleges and simple randomization for the selection of participants. Study area is Greater Chennai Corporation. Enrolment criteria is participants who satisfy the inclusion and exclusion criteria. Disease to be targeted are Dysmenorrhoea Menorrhagia Oligomenorrhea and Metrorrhagia. The project proposal has been obtained IECapproval from The Tamil Nadu Dr.M.G.R Medical University Chennai IEC.NO. ECMGR0309243 dated 18.11.2023 and IEC approval from DPHPM Chennai IEC NO. DPHPM/IEC/2025/006 dated 15.04.2025. Screening is done through using a pretested and validated questionnaire. Later will interviewed for the presence of any discomforts or abnormalities with relation to the menstruation. Each week 2 or 3 alternative days will be allotted for this baseline survey until the expected number of 1,50,000 women are interviewed. Study also includes awareness programme related to the topic and counselling for both the participants Non- participants and parents . This also includes awareness camp regarding pre and post test for the participants. The selection of study participants would be based on the severity of the menstrual disorders they have and their willingness to be a part of the study. Ethical considerations areBefore enrollment for Siddha intervention informed written consent assent  form parental consent form of the participants or parents will be obtained and patient information sheet will be provided. A separate file or folder will be maintained for each patients and documented. The privacy of the participants will be strictly maintained. Once the participants is beenenrolledevery 15 days once the set of 3 Siddha medicines will be dispensed to the participants according to their diagnosis dosage and the outcome will be recorded. Totalduration is 3-4 cycles (120 days). This protocol is same for all the four menstrual disorders.  The medicines will be purchased from GMP certified Siddha Medicines manufacturing Companies as per the projected expectations. For selected participants investigations will be taken in NABL labs nearby schools or colleges. Base-line clinical investigation data and periodical data will be documented and entered using excel. Pre and post intervention areinvestigations and symptoms list or severity etc prior to treatment and post treatment will be done and documented. The following statistical test will be conducted to obtain the outcome of the project for estimation of prevalence of menstrual disorders, frequency and percentage of menstrual disorders among school and college students and CHC and DH patients. Mean, median, standard deviation and interquartile range for continuous variables. Estimate point prevalence stratified prevalence based on age groups educational institutions and health care settings. For baseline comparison t test or non parametric test independent t test or ANOVA chi square test or Fisher’s exact test and Logistic regression will be done. For pre post comparison of laboratory & USG findings logistic regression, linear regression Mcnemar, Paired t test will be done. Intermediate and final statistical analysis will be performed and submitted to the Ministry of AYUSH in proper format as per the regulations. The details of the beneficiaries of the initiative will be documented and maintained both in the hard copy and soft copy forms . Periodical reports will be submitted to the funding agency as required. Outcome of the study are The benefits of siddha system of  medicine will be made available to the women community. The health issues affecting the women will be well addressed and Their level of health and productivity will be enhanced by reducing the absenteeism in schools and colleges which will improve their quality of education. The benefits and effectiveness of siddha medicines for gynecological health issues will be documented. The prevalence of menstrual abnormalities will  be accessed. Community be will be benefited through free supply of siddha medicines and free gynecologist consultation.