| CTRI Number |
CTRI/2025/07/090997 [Registered on: 16/07/2025] Trial Registered Prospectively |
| Last Modified On: |
14/07/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Diagnostic |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Life Style Modification (LSM) Protocol on thyroid dysfunction and menstrual irregularities among adolescent girls |
|
Scientific Title of Study
|
Development, Validation and Evaluation of comparative efficacy of Community Based Nurse Led Life Style Modification (LSM) Protocol versus conventional care on thyroid dysfunction and menstrual irregularities among adolescent’s girls |
| 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 Manjusha Mahakarkar |
| Designation |
Ph D Scholar |
| Affiliation |
Datta Meghe Institute of Higher Education and Research Deemed to be University |
| Address |
Department of OBGY Nursing
Smt Radhikabai Meghe Memorial College of Nursing
Datta Meghe Institute of Higher Education and Research Deemed to be University
Sawangi Meghe
Wardha
Wardha
MAHARASHTRA
442001
India |
| Phone |
9766565719 |
| Fax |
|
| Email |
manjum4725@gmail com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Kavita Gomase |
| Designation |
Assistant Professor |
| Affiliation |
Datta Meghe Institute of Higher Education and Research Deemed to be University |
| Address |
Department of OBGY Nursing
Smt Radhikabai Meghe Memorial College of Nursing
Datta Meghe Institute of Higher Education and Research Deemed to be University
Sawangi Meghe
Wardha
Wardha
MAHARASHTRA
442001
India |
| Phone |
9175515580 |
| Fax |
|
| Email |
kavitapravin3@gmail com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Kavita Gomase |
| Designation |
Assistant Professor |
| Affiliation |
Datta Meghe Institute of Higher Education and Research Deemed to be University |
| Address |
Department of OBGY Nursing
Smt Radhikabai Meghe Memorial College of Nursing
Datta Meghe Institute of Higher Education and Research Deemed to be University
Sawangi Meghe
Wardha
Wardha
MAHARASHTRA
442001
India |
| Phone |
9175515580 |
| Fax |
|
| Email |
kavitapravin3@gmail com |
|
|
Source of Monetary or Material Support
|
| Datta Meghe Institute Of Higher Education and Research Sawangi Meghe
Wardha
MAHARASHTRA
442001
|
|
|
Primary Sponsor
|
| Name |
Datta Meghe Institute of Higher Education and Research |
| Address |
Sawangi Meghe Wardha India 442001
|
| Type of Sponsor |
Private medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Manjusha Mahakalkar |
8th to 10th std adolscents girl, Alponsa Higher Secondary school |
Alponsa Higher Secondary school, Sawangi Meghe Wardha.
Wardha
MAHARASHTRA |
9766565719
manjum4725@gmail.com |
| Ms Manjusha Mahakarkar |
Alponsa Hiher Secondary School |
8th std class Sawangi Meghe Wardha
Wardha
MAHARASHTRA |
9766565719
manjum4725@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| DattaMeghe Institute of Higher Education and Research Wardha |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E00-E89||Endocrine, nutritional and metabolic diseases, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Community-Based Nurse Led Life lifestyle modification (LSM) Protocol |
Community Based Nurse Led Life Style Modification (LSM) Protocol will be implement for 6 months. |
| Comparator Agent |
Conventional care |
Conventional care for thyroid dysfunction and menstrual irregularities in adolescent girls involves early identification, accurate diagnosis, and a multidisciplinary treatment approach. Common thyroid conditions include hypothyroidism, hyperthyroidism, and autoimmune disorders like Hashimoto’s or Graves’ disease, typically diagnosed through clinical evaluation and thyroid function tests (TSH, Free T4, T3, and antibodies), with treatment involving levothyroxine for hypothyroidism and methimazole or beta-blockers for hyperthyroidism. |
|
|
Inclusion Criteria
|
| Age From |
15.00 Year(s) |
| Age To |
19.00 Year(s) |
| Gender |
Female |
| Details |
Those adolescent girls between the ages of fifteen to nineteen
Those who are willing to participate in the study
Those who have mild and moderate levels of hypothyroidism
Those who have hypothyroidism with anemia obesity PCOS
|
|
| ExclusionCriteria |
| Details |
1.Those who have severe levels of thyroid
2.Those who are married and pregnant or breastfeeding.
3.Those taking dietary supplements like selenium or iodine.
4.Those who are adolescent girls taking all of the drug classes of antidepressants, and steroids, suffering from Diabetes Mellitus, chronic and acute renal failure, and stroke, those who are suffering from asthma and sinus problems, and those who have a cold and cough.
|
|
|
Method of Generating Random Sequence
|
Adaptive randomization, such as minimization |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Early of improvement in menstrual cycle in adolescent girls |
Assessment will be done at three month and six month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Change in knowledge of health professional regarding Community Based Nurse Led Life Style Modification (LSM) Protocol
|
Assessment will be done at the end of six month |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
22/09/2025 |
| 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="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
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
|
Menstrual
irregularities
are common problem among adolescent
girls in the
reproductive age and pose a huge burden on gynecology OPD, accounting for
approximately 20% of attendance. These causes
significant social embarrassment, affects quality of life and productivity,
imposes financial burden and also leads to surgical interventions like curettage. In India, thyroid disorders are among
the most common endocrine diseases. According to the National Family Health
Survey (2019-21) under the parameters of goiter or thyroid disorders the
prevalence is 2.7% for women out of
which 0.7 % is the 15-19 years
adolescents age group. Thyroid hormones have important role in
normal reproductive physiology both by directly effecting the ovaries and
indirectly by interacting with sex
hormone-binding globulin. Thyroid
disorders are commoner in women than in men and leads to abnormal sexual
development, menstrual disorders, infertility and premature menopause. |