| CTRI Number |
CTRI/2019/11/022122 [Registered on: 22/11/2019] Trial Registered Prospectively |
| Last Modified On: |
02/08/2021 |
| Post Graduate Thesis |
No |
| Type of Trial |
PMS |
|
Type of Study
|
Nutraceutical |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Safety and Efficacy of D-chiro inositol and myo-inositol combination in women with Polycystic ovarian syndrome. |
|
Scientific Title of Study
|
"A Prospective, Open label, single-center, single arm, post marketing study to evaluate the efficacy and safety of D-chiro inositol and myoinositol combination on ovarian function and metabolic factors in women with Polycystic ovarian syndrome (PCOS)" |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NORMOZ001 Version 1.0 26 September 2019 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Garima Kachhawa |
| Designation |
Associate Proffesor |
| Affiliation |
All India institute of Medical sciences |
| Address |
AIIMS NEW DELHI
New Delhi
New Delhi
DELHI
110029
India |
| Phone |
|
| Fax |
|
| Email |
garimakachhawa2012@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Garima Kachhawa |
| Designation |
PRINCIPAL INVESTIGATOR |
| Affiliation |
All India institute of Medical sciences |
| Address |
AIIMS NEW DELHI
room 3086, 3rd floor, teaching block, aiims, new delhi
New Delhi
DELHI
110029
India |
| Phone |
|
| Fax |
|
| Email |
garimakachhawa2012@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Garima Kachhawa |
| Designation |
Medical Advisor |
| Affiliation |
All India institute of Medical sciences |
| Address |
aiims new delhi
room 3086, 3rd floor, teaching block, aiims, new delhi
New Delhi
DELHI
110029
India |
| Phone |
|
| Fax |
|
| Email |
garimakachhawa2012@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sun Pharma Laboratories Ltd
Sun House, Western Express Highway , Jogeshwari, Mumbai 400063 |
|
|
Primary Sponsor
|
| Name |
Sun Pharma Laboratories Ltd |
| Address |
Sun House, 201/B1, Western Express Highway,
Goregaon ( East ), Mumbai,
Maharashtra ( India ) – 400 063
|
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
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 Garima Kachhawa |
All India Institute of Medical Sciences |
All India Institute of Medical
Sciences, room no 3086, 3rd floor, teaching block
Ansari Nagar New Delhi - 110029
North
DELHI |
1126588500
garimakachhawa2012@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute EthicsCommittee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N74||Female pelvic inflammatory disorders in diseases classified elsewhere, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Chromium picolinate 100 MCG WITH D-chiro-Inositol 13.8 MG WITH Myo-inositol 550 MG WITH Vitamin D3 200 IU |
Orally once daily after the meal |
| Comparator Agent |
Not Applicable |
Not Applicable |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
1.Female subjects oligo menorrhea, amenorrhea with Polycystic ovarian syndrome (PCOS), aged 18 years to 40 years old and meet the following criteria:
2.Female subjects 18 years to 40 years (both inclusive) oligo menorrhea, amenorrhea with Polycystic ovarian syndrome (PCOS).
3.Subjects who are known cases of PCOS as per the Rotterdam Criteria, which requires presence of 2 of the following 3 conditions:
-oligo/anovulation
-hyperandrogenism- clinical (hirsutism or less commonly male pattern alopecia) or biochemical (raised free androgen index or free testosterone)
-Polycystic ovaries on ultrasound (≥10 small antral follicles seen in each ovary)
4.Subjects with primary or secondary infertility (with PCOS as the apparent cause), and attempting to conceive at the time of signing ICF.
5.Patients with BMI between 18-29 kg/m2 (both inclusive) at the time of screening.
|
|
| ExclusionCriteria |
| Details |
1.Systemic diseases- Renal, hepatic cardiac, RS , frank DM, hypertension ,
congenital adrenal hyperplasia, ,hyperprolactinemia, acromegaly,
functional hypothalamic amenorrhea.
2.Past H/O lactic acidosis.
3.Patients undergoing IV contrast media study or surgical procedures.
4.BMI ( >29 mg/) kg.
5.Any ovarian and/or abdominal abnormality interfering with ultrasound examination.
6.History / presence of undiagnosed vaginal bleeding.
7.History of clinically significant endocrine related abnormality .
8.Subject with history of abnormal thyroid function, congenital adrenal hyperplasia, or any other adrenal, pituitary, or ovarian condition that may be the cause of hyperandrogenism and/or anovulation. hyperprolactinemia, Addison and Cushing.
9.Subject in whom infertility is related to male factors, or female factors including uterine, tubal or cervical abnormality, primary/premature ovarian failure, pelvic infections, or adhesions etc.
10.Subject has received hormonal preparations, including oral/injectable contraceptive preparation in the past 6 months.
11.Subject is receiving drugs that can potentially influence ovulation, insulin resistance, and body weight (e.g. anti-epileptics, anti-psychotics, sulfonylureas, insulin sensitizers, corticosteroids, etc) within 5-half-lives prior to screening. Intermittent oral corticosteroids (≤10 mg/day of prednisolone equivalent for ≤7 days at a time, or chronic inhaled corticosteroids will be permitted).
12.Subject with history of or who test positive for Human Immunodeficiency Virus, Hepatitis B or Hepatitis C infection at screening.
13.Subject known to be allergic, hypersensitive, or intolerant to any of the contents of Normoz.
14.Subject who smokes or has stopped smoking within the last 3 months prior to screening.
15.Subject with history of alcohol or drug abuse within 6 months prior to screening.
16.Subject with history of epilepsy, thrombophilia, cardiovascular, gastrointestinal, hepatic, renal, pulmonary, auto-immune disease or any active infection, requiring treatment which at the investigator’s discretion might interfere with the study.
17.Subject with history of malignancy.
18.Subject who has received an investigational product or has used an invasive investigational medical device within 30 days before the planned first dose of the study drug; or is currently enrolled in an investigational study.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.To evaluate the regularization of Menses
2.To assess the Improvement in Ovulatory function
3.To assess the proportion of subjects achieving spontaneous ovulation at the end of 3 months.
4.To evaluate the normalization of Thyroid Profile
5.To evaluate the regularization of Menses
6.To assess the Improvement in Ovulatory function
7.To assess the proportion of subjects achieving spontaneous ovulation at the end of 3 months.
8.To evaluate the normalization of Thyroid Profile
|
1.Regularization of Menses measured by change from baseline to Month 6(3rd Month Interim).
2.Improvement in Ovulatory function measured by change from baseline to Month 6(3rd Month Interim).
3.Normalization of Thyroid Profile measured by change from baseline to Month 6(3rd Month Interim).
4.Proportion of subjects achieving spontaneous ovulation at the end of 3 months of treatment with Normoz. (0,3 months)
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Improvement in clinical features of PCOS
2.change in oral glucose tolerance test
3.normalization of BMI.
4.change in Endocrine parameters in non-pregnant subjects
5.change in serum androgen levels in non-pregnant subjects
6.change in glycemic parameters in non-pregnant subjects
7.change in lipid parameters in non-pregnant subjects
8.Normalization of menstrual cycle in non-pregnant subjects
9.Clinical pregnancy rate
10.safety of D-CHIRO INOSITOL AND MYO-INOSITOL COMBINATION |
1.change from baseline to Month 6(3rd Month Interim).
2.change from baseline to Month 6(3rd Month Interim).
3.change from baseline to Month 6(3rd Month Interim).
4.baseline to 3 months of treatment with STUDY DRUG, in non-pregnant subjects.
5.baseline to 3 months of treatment with STUDY DRUG in non-pregnant subjects
6.baseline to 3 months of treatment with STUDY DRUG in non-pregnant subjects.
7.baseline to 3, 6 months of treatment with STUDY DRUG in non-pregnant subjects. |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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
|
Post Marketing Surveillance |
|
Date of First Enrollment (India)
|
28/11/2019 |
| 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="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This is A prospective, open-label, Single-center,
single arm post-marketing study to evaluate the efficacy and safety of Normoz
on ovarian function and metabolic factors in women with Polycystic ovarian
syndrome (PCOS). The study intends to recruit 100
patients from 1 site in India who fit the eligibility
criteria and provide informed consent to participate in the study. Normoz is one of the
standard treatments for this condition. Being an open label study there will be
no blinding procedures.
|