| CTRI Number |
CTRI/2018/10/016091 [Registered on: 22/10/2018] Trial Registered Prospectively |
| Last Modified On: |
06/12/2019 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Nutraceutical |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Clinical Study on Mtorr 800 Capsules to treat Poor Ovarian Health and Aid Conception |
|
Scientific Title of Study
|
A Double Blinded, Prospective, Comparative, Placebo controlled, Two Arm Clinical Study to Evaluate the Efficacy and Safety of Mtorr 800 Capsules in the Treatment of Poor Ovarian Response in Adult Women to aid Conception |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| AHC/INF/044/18 Version 02 Dated 17-Aug-18 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr VT Sriraam |
| Designation |
Chief Medical Research Coordinator |
| Affiliation |
Aurous HealthCare R & D India Private Limited |
| Address |
180/109, G1 and G2, RR Villa,
Rangarajapuram Main Road,
Kodambakkam
Chennai
Chennai
TAMIL NADU
600024
India |
| Phone |
9840909155 |
| Fax |
|
| Email |
md@auroushealthcare.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr VT Sriraam |
| Designation |
Chief Medical Research Coordinator |
| Affiliation |
Aurous HealthCare R & D India Private Limited |
| Address |
180/109, G1 and G2, RR Villa,
Rangarajapuram Main Road,
Kodambakkam
Chennai
Chennai
TAMIL NADU
600024
India |
| Phone |
9840909155 |
| Fax |
|
| Email |
md@auroushealthcare.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr VT Sriraam |
| Designation |
Chief Medical Research Coordinator |
| Affiliation |
Aurous HealthCare R & D India Private Limited |
| Address |
180/109, G1 and G2, RR Villa,
Rangarajapuram Main Road,
Kodambakkam
Chennai
Chennai
TAMIL NADU
600024
India |
| Phone |
9840909155 |
| Fax |
|
| Email |
md@auroushealthcare.com |
|
|
Source of Monetary or Material Support
|
| Nutri Synapzz Therapeutix Private Limited |
|
|
Primary Sponsor
|
| Name |
Nutri Synapzz Therapeutix Private Limited |
| Address |
#203, 2nd floor BEML,IVth stage
Raja Rajeshwari Nagar Bangalore – 560098
Karnataka. India. |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Aurous HealthCare Research and Development India Private Limited |
180/109, G1 and G2, RR Villa,
Rangarajapuram Main Road,
Kodambakkam, Chennai - 600024
Tamil Nadu |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Kshitiz Murdia |
Indira IVF Hospital Private Limited |
Department of Infertility
Number 44,Amar Niiwas,Opposite MB College,
Kumharo ka bhatta ,Udaipur 313001
Rajasthan, India.
Udaipur
RAJASTHAN |
9799112244
drkshitiz@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Human Research Ethics Committee, Geetanjali Medical College and Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N979||Female infertility, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Mtorr 800 Capsules |
Intended for the treatment of Female Infertility (Poor Ovarian Response).
Dosage: 1 Capsule Once a day, for 3 months.
|
| Comparator Agent |
Placebo |
No effect.
Dosage: 1 Capsule Once a day, for 3 months.
|
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
1. Female between the ages of 25 and 45 (both ages inclusive), in a monogamous, heterosexual marriage, trying to conceive and having difficulty with conception.
2. Subjects with AMH Levels ≤1.5 ng/ml at the time of screening.
3. Subjects with AFC (2mm-5mm) ≤4 at the time of screening.
4. Subjects who have not conceived after 1 year of unprotected vaginal sexual intercourse; with or without history of ART treatments.
5. Subjects with primary or secondary infertility.
6. Subjects with normal USG of pelvis with normal uterus.
7. Subjects with normal clinical breast examination.
|
|
| ExclusionCriteria |
| Details |
1. Subjects with pelvic pathology that compromise study objectives ,inclusive of undiagnosed vaginal bleeding.
2. Subjects who have history of insulin dependent and non-insulin dependent diabetes mellitus.
3. Subjects who are currently on or have been on follicle stimulating hormone therapy for upto 3 months prior to screening.
4. Subjects with Grade III or IV endometriosis.
5. Subjects who have history/diagnosis of cancer inclusive of subjects in remission.
6. Subjects with history of significant risk for breast cancer,endometrial cancer.
7. Subjects who have fibroadenomas in either breast and/or uterine myoma as diagnosed upto 1 year prior to screening; if not removed surgically.
8. Subjects with known history of clinically significant gastrointestinal, cardiovascular, hematological, hepatic,
immunological, renal, respiratory, neurological abnormalities or diseases.
9. Subjects who have undergone major surgical procedure 4 weeks prior to screening.
10. Subjects with diagnosis of HIV, HCV, HBV and other sexually transmitted diseases.
11. Subjects who are on steroids, anti-depressants, anti-psychotics.
12. Subjects who have participated in another clinical study upto 3 months prior to screening.
13. Subjects who mentally unable to comprehend the responsibilities and adhere to the stipulations of the protocol.
14. Subjects who in the opinion of the investigator are deemed unfit to participate in the study.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Pre-numbered or coded identical Containers |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Anti Mullerian Hormone : ≥50% increase in AMH Levels by end of study.
2. Anti Mullerian Hormone : AMH Levels of ≥4 ng/ml by end of study.
3. Antral Follicular Count : ≥50% increase in AFC (minimum of 2-5mm) by end of study.
4. Subject Compliance and Satisfaction: Score of ≥20 by end of study. |
1. Anti Mullerian Hormone :At Visit 1(Day 1), Visit 3
(Day 90).
2. Antral Follicular Count : At Visit 1 (Day 1),Visit 3
(Day 90).
3. Subject Compliance and Satisfaction:At Visit 2
(Day 45), Visit 3 (Day 90).
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Anti Mullerian Hormone : 25-49% increase in AMH Levels by end of study.
2. Antral Follicular Count : 25-49% increase in AFC (minimum of 2-5mm) by end of study.
3. Subject Compliance and Satisfation: Score of 15-19 by end of study.
|
1. Anti Mullerian Hormone :At Visit 1(Day 1), Visit 3
(Day 90).
2. Antral Follicular Count : At Visit 1 (Day 1),Visit 3
(Day 90).
3. Subject Compliance and Satisfaction:At Visit 2
(Day 45), Visit 3 (Day 90).
|
|
|
Target Sample Size
|
Total Sample Size="114"
Sample Size from India="114"
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)
|
30/10/2018 |
| 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="0"
Months="3"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
Not Applicable |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Study Design: A Double Blinded, Prospective, Comparative, Placebo
Controlled, Two Arm Clinical Study.
Study Population: Females between the ages of 25 and 45 years (both ages
inclusive) in a monogamous, heterosexual marriage, trying to conceive but
having difficulty with conception.
Indication: Female Infertility (Poor Ovarian Response)
Investigational Product Test: Mtorr 800 Capcules
Investigational Product Comparator: Placebo Capsules
Dosage: 1 OD x 3 months (1 capsule once a day, for 3 months)
Study Duration: 3 months
Number of Subjects: 114 subjects (so as to reach 102 evaluable subjects)
Assessments:
1. Anti Mullerian Hormone Test
2. Antral Follicular Count
3. Complete Blood Count
4. Serum Biochemistry (including LFT
and RFT)
5.. Subject IP Feedback
Questionnaire |