| CTRI Number |
CTRI/2024/06/068833 [Registered on: 12/06/2024] Trial Registered Prospectively |
| Last Modified On: |
03/06/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Scope of Homoeopathy in menstrual disturbances of adolescent girls |
|
Scientific Title of Study
|
Scope of Homoeopathy in menstrual disturbances of adolescent girls – A Multi-centric, Prospective study |
| 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 Manas R Sarangi |
| Designation |
Research Officer (H)/ Scientist-3, CCRH Hqrs, New Delhi. |
| Affiliation |
|
| Address |
CENTRAL COUNCIL FOR RESEARCH IN HOMOEOPATHY,
Clinical Research Division,
Room No.-406, 61-65, Institutional Area, Opp. ‘D’ Block, Janak Puri, New Delhi – 110058, India.
West
DELHI
110058
India |
| Phone |
9968091251 |
| Fax |
|
| Email |
drmanas2k@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Manas R Sarangi |
| Designation |
Research Officer (H)/ Scientist-3, CCRH Hqrs, New Delhi. |
| Affiliation |
|
| Address |
CENTRAL COUNCIL FOR RESEARCH IN HOMOEOPATHY,
Clinical Research Division,
Room No.-406
61-65, Institutional Area, Opp. ‘D’ Block, Janak Puri, New Delhi – 110058, India.
West
DELHI
110058
India |
| Phone |
9968091251 |
| Fax |
|
| Email |
drmanas2k@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Manas R Sarangi |
| Designation |
Research Officer (H)/ Scientist-3, CCRH Hqrs, New Delhi. |
| Affiliation |
|
| Address |
CENTRAL COUNCIL FOR RESEARCH IN HOMOEOPATHY,
Clinical Research Division,
Room no. 406,
61-65, Institutional Area, Opp. ‘D’ Block, Janak Puri, New Delhi – 110058, India.
West
DELHI
110058
India |
| Phone |
9968091251 |
| Fax |
|
| Email |
drmanas2k@gmail.com |
|
|
Source of Monetary or Material Support
|
| CENTRAL COUNCIL FOR RESEARCH IN HOMOEOPATHY
61-65, Institutional Area, opposite D Block, Janakpuri.
New Delhi-110058 |
|
|
Primary Sponsor
|
| Name |
CENTRAL COUNCIL FOR RESEARCH IN HOMOEOPATHY |
| Address |
61-65, Institutional Area, Opp. ‘D’ Block, Janak Puri, New Delhi – 110058, India. |
| Type of Sponsor |
Research institution |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 4 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Suraia Parveen |
Dr. Anjali Chatterjee Regional Research Institute (H), Kolkata. |
50, RAJENDRA CHATTERJEE ROAD, KOLKATA-700035
Kolkata
WEST BENGAL |
92312758284
drsuraia@gmail.com |
| Dr Padmalaya Rath |
Dr. D.P. Rastogi Central Research Institute (H) |
A-1/1, Sector 24, NOIDA, Gautambudh Nagar, 201301 (U.P.)
Ghaziabad
UTTAR PRADESH |
9811704560
drpadmalaya@gmail.com |
| Dr Sujata Choudhury |
Drug Proving Unit, unit of CCRH |
Abhin Chandra Homoeopathic Medical College & Hospital, Unit - III , Bhubaneswar
Pin - 751001 (Odisha)
Khordha
ORISSA |
9040866185
drsujatamd@gmail.com |
| Dr Tejaswini Patole |
Regional Research Institute (H) |
Plot No. 38-39, Sector 18, Khargar, Navi Mumbai-410210
Mumbai
MAHARASHTRA |
8794903345
tejaswini74@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 5 |
| Name of Committee |
Approval Status |
| CEC DDPRCRI NOIDA |
Approved |
| Central Ethics Committee of CCRH |
Approved |
| IEC, DACRRIH, Kolkata |
Approved |
| IEC, RRI(H) Navi Mumbai |
Approved |
| IEC, RRI(H), Puri |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E282||Polycystic ovarian syndrome, (2) ICD-10 Condition: E289||Ovarian dysfunction, unspecified, (3) ICD-10 Condition: E288||Other ovarian dysfunction, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
12.00 Year(s) |
| Age To |
18.00 Year(s) |
| Gender |
Female |
| Details |
1. Unmarried Females in the age group 12 to 18 years.
2. Females with menstrual abnormalities like amenorrhea, oligomenorrhoea, dysmenorrhoea, dysfunctional uterine bleeding.
3. Females not undergoing conventional treatment or any hormonal therapy.
4. Females who have given the written informed consent. |
|
| ExclusionCriteria |
| Details |
1. Female below the age of 12 years and above the age of 18 years.
2. Females with abnormal findings on levels of Prolactin, TSH, T3, T4.
3. Females taking conventional treatment or any hormonal therapy.
3. Females taking medication for any other severe illness.
4. Females during pregnancy and lactation.
5. Females with no written informed consent.
|
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
• Clinical Assessment using MYMOP2, ORIDL at every month up to 12 months
• Adolescent health assessment using WHO-5 index and Warwick-Edinburgh Mental Wellbeing scale |
• Every month, upto 12 months.
• Baseline, 3 months, 6 months, 9 months and 12 months. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| • Assessment of serum levels of LH, FSH, Oestradiol, free Testosterone, Dehydroepiandrosterone (DHEA), Prolactin, TSH, T3, T4, Lipid profile, Glucose tolerance test, Ultrasonography of abdomen and pelvis |
Baseline, 6th month and 12th month. |
|
|
Target Sample Size
|
Total Sample Size="240"
Sample Size from India="240"
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)
|
01/07/2024 |
| 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="6"
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
|
This study is multicentric prospective single arm study to observe and analyze the effectiveness of Individualized Homoeopathy Medicines for the treatment of menstrual disorders among the unmarried adolescent girls aged between 12- 18 years. The study will be conducted at four different centers in India, which includes at Noida, Puri, Kolkata and Mumbai for a period of 2 years and 6 months. The primary outcome will be done by using MYMOP2, ORIDL for Clinical Assessment at every month up to 12 months and Adolescent health assessment using WHO-5 index and Warwick-Edinburgh Mental Wellbeing scale at base line, 3 months, 6 months, 9 months and 12 months. The secondary outcome will done by the assessment of serum levels of LH, FSH, Oestradiol, free Testosterone, Dehydroepiandrosterone (DHEA), Prolactin, TSH, T3, T4, Lipid profile, Glucose tolerance test, Ultrasonography of abdomen and pelvis at baseline, 6th month and 12th month. Homoeopathic medicines have been found useful in managing the signs and symptoms observed in menstrual disorders but meager documentation has been done about the effectiveness of homoeopathy medicines in treating such cases. So this study is proposed to see the effectiveness of homoeopathic intervention in the management of menstrual disorders in adolescence.
|