| CTRI Number |
CTRI/2025/05/087447 [Registered on: 22/05/2025] Trial Registered Prospectively |
| Last Modified On: |
30/09/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Siddha
Screening |
| Study Design |
Other |
|
Public Title of Study
|
Siddha Medicines for Menstrual health, A promising approach for young girls |
|
Scientific Title of Study
|
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. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DrNKabilan |
| Designation |
Professor and Head of Department of Siddha |
| Affiliation |
The Tamil Nadu Dr.M.G.R Medical University. |
| Address |
Department of Siddha,
The Tamil Nadu Dr.M.G.R Medical University,
Anna Salai,
Guindy, Chennai-32
Department of Siddha,
The Tamil Nadu Dr.M.G.R Medical University,
Anna Salai,
Guindy, Chennai- 32
Chennai
TAMIL NADU
600032
India |
| Phone |
9444018139 |
| Fax |
|
| Email |
kabilan.n@tnmgrmu.ac.in |
|
Details of Contact Person
Scientific Query
|
| Name |
DrNKabilan |
| Designation |
Professor and Head of Department of Siddha |
| Affiliation |
The Tamil Nadu Dr.M.G.R Medical University. |
| Address |
Department of Siddha,
The Tamil Nadu Dr.M.G.R Medical University,
Anna Salai,
Guindy, Chennai-32
Department of Siddha,
The Tamil Nadu Dr.M.G.R Medical University,
Anna Salai,
Guindy, Chennai- 32
Chennai
TAMIL NADU
600032
India |
| Phone |
9444018139 |
| Fax |
|
| Email |
kabilan.n@tnmgrmu.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
DrNKabilan |
| Designation |
Professor and Head of Department of Siddha |
| Affiliation |
The Tamil Nadu Dr.M.G.R Medical University. |
| Address |
Department of Siddha,
The Tamil Nadu Dr.M.G.R Medical University,
Anna Salai,
Guindy, Chennai-32
Department of Siddha,
The Tamil Nadu Dr.M.G.R Medical University,
Anna Salai,
Guindy, Chennai- 32
Chennai
TAMIL NADU
600032
India |
| Phone |
9444018139 |
| Fax |
|
| Email |
kabilan.n@tnmgrmu.ac.in |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Ministry of AYUSH |
| Address |
Ministry of AYUSH,
Ayush Bhavan,
B Block, GPO, Complex,
Barapullah Rd, Aviation Colony,
INA Colony, New Delhi,
Delhi - 110023 |
| Type of Sponsor |
Government funding agency |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr N Kabilan |
All Schools, Colleges and PHC/CHC of Greater Chennai Corporation |
Room No 9,Department of Siddha, The Tamil Nadu Dr.M.G.R Medical University, Anna Salai, Guindy, Chennai.
Chennai
TAMIL NADU |
09444018139
kabilan.n@tnmgrmu.ac.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE, DIRECTORATE OF PUBLIC HEALTH AND PREVENTIVE MEDICINE,CHENNAI |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E35||Disorders of endocrine glands in diseases classified elsewhere, (2) ICD-10 Condition: N948||Other specified conditions associated with female genital organs and menstrual cycle, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NOT APPLICABLE |
NOT APPLICABLE |
| Intervention |
Siddha Medicine Intervention. |
Study aim is to find the effectiveness of Siddha medicine for most common menstrual disorders like Dysmenorrhea, Oligomenorrhea, Menorrhagia, Metrorrhagia among School or college adolescent girls of age group 15-25 years. Medicines used for intervention will be purchased from GMP certified pharma. Siddha medicines subjected in the study comprises around 3 medicines for each disorder which are available in market for long period of time. The total study participants for intervention are 1250 that is 0.6 percentage of total screening population of about 1,50,000. |
|
|
Inclusion Criteria
|
| Age From |
15.00 Year(s) |
| Age To |
25.00 Year(s) |
| Gender |
Female |
| Details |
Those who attained menarche three years before
Presence of any of the following abnormality related to menstruation with or without laboratory investigations like
Excessive or prolonged or intermittent or Inconsistent bleeding.
Discomfort or cramps or radiating pain in the lower abdomen or lower back or pelvic region during or around menses.
Scanty menstruation and Inconsistent bleeding during each period
Abnormal hair growth or Mood swings or irritability during or around periods
If symptoms persist despite three months of empiric treatment.
Presence of following menstrual disorders namely dysmenorrhea or menorrhagia or metrorrhagia or oligomenorrhea for past 3months of period will be included for intervention. Other menstrual disorders like Leucorrhoea or Amenorrhoea will also be addressed and referred. If primary amenorrhoea with age above 15 years will be excluded from study and refer to CEmONC and any secondary amenorrhoea also be excluded after counselling and refer to CEmONC in nearby medical colleges.
|
|
| ExclusionCriteria |
| Details |
•Adolescent Girls / Women being treated with Allopathic, Ayurvedic and Unani medicines for the same condition and unwilling to participate in the current trial.
•Adolescent Girls / Women under the treatment of other hormonal drugs, seizures drugs and steroids.
•Having conditions like Rheumatoid Arthritis, Rheumatic conditions, DM, CVS and Renal diseases.
•Any known case of diagnosed genetic diseases
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
The prevalence of Menstrual Abnormalities will be assessed.
The health issues affecting the Women will be well addressed. Their level of health and productivity will be enhanced
The benefits and effectiveness of Siddha medicines for Gynecological health will be documented.
|
At baseline and after 120 days of treatment
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| The benefits of Siddha system of medicine will be made available to the Women community |
at the baseline & after 120 days of treatment |
|
|
Target Sample Size
|
Total Sample Size="1250"
Sample Size from India="1250"
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)
|
25/05/2025 |
| 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)
Modification(s)
|
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
|
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 objective of 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 is cross 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 size of 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 IEC approval 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 are Before 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 been enrolled every 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. Total duration 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 are investigations 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. |