| CTRI Number |
CTRI/2018/04/013334 [Registered on: 18/04/2018] Trial Registered Prospectively |
| Last Modified On: |
21/04/2018 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Clinical study to evaluate the effectiveness of plant extract based natural oils MJR(F), Yin(PC) and Endobal abdominal massage in management of Polycystic Ovarian Syndrome |
|
Scientific Title of Study
|
A randomized, double blind, placebo-controlled, study to evaluate the effectiveness of plant extract based natural oils MJR(F), Yin(PC) and Endobal abdominal massage in management of Polycystic Ovarian Syndrome (PCOS) |
| Trial Acronym |
PCOS |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Rashee Jain |
| Designation |
Consultant Gynecologist |
| Affiliation |
Brij Medical Centre, Kanpur |
| Address |
Brij Medical Centre, Panki Kanpur
Kanpur Nagar
UTTAR PRADESH
208020
India |
| Phone |
9866330090 |
| Fax |
|
| Email |
bmcpanki@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Anit Singh MD |
| Designation |
Medical Director |
| Affiliation |
Clinical Research Network India |
| Address |
Inox Tower Sector 16A Noida
Gautam Buddha Nagar
UTTAR PRADESH
201301
India |
| Phone |
9866330090 |
| Fax |
|
| Email |
medicalmonitor@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Anit Singh MD |
| Designation |
Medical Director |
| Affiliation |
Clinical Research Network India |
| Address |
Inox Tower Sector 16A Noida
Gautam Buddha Nagar
UTTAR PRADESH
201301
India |
| Phone |
9866330090 |
| Fax |
|
| Email |
medicalmonitor@gmail.com |
|
|
Source of Monetary or Material Support
|
| GODS OWN STORE
A-89 Amritpuri, East of Kailash
|
|
|
Primary Sponsor
|
| Name |
Gods Own Store |
| Address |
GODS OWN STORE
A-89 Amritpuri, East of Kailash
|
| 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 Rashee Jain |
Brij Medical Center |
Brij Medical Center Panki, Kanpur
Kanpur Nagar
UTTAR PRADESH |
9866330090
bmcpanki@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics Committee Brij Medical Center |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Polycystic Ovarian Syndrome PCOS, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Placebo |
Blend of Oil Soyabean, Sunflower, Mustard
|
| Intervention |
Plant extracts based natural oil blends |
MJR(F), Yin(PC) and Endobal |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
1. Married Female patients of age group 18-40 years diagnosed with polycystic ovarian syndrome/disease (PCOS or PCOD) and suffering from primary infertility, irregular/scanty menses due to anovulatory cycles and increased LH levels in blood will be included in the study.
2. LH: FSH ratio > 3 confirmed by hematological examinations, will be enrolled in the study.
3. Subjects with clinical or biochemical evidence of Hyperandrogenism will be included.
4. Subjects must have a negative pregnancy test. Pregnant patients and lactating mothers will be excluded from the study.
5. Participants should be willing to sign a written consent for participation in the study and undergo a baseline interview.
6. Participants must be willing to commit to medication dosing and assessment visits for evaluation.
7. Participants must be willing to refrain from taking any other medications for treatment of PCOD, irregular menses and infertility including HRT from the outset of the study until final evaluation (if patient force to take above said medicine, subject will be dropped from the study).
8. Participants must agree that during the study they will refrain from taking any new herbal supplement and prescription or nonprescription medications without prior approval of the research team.
9. Participants must agree to take healthy diet and life style. |
|
| ExclusionCriteria |
| Details |
1. Unmarried subjects,
2. subjects who are pregnant or lactating mothers.
3. Patients currently on HRT or having taken any herbal medications in the last 30 days will be excluded from the study.
4. Patients diagnosed with cervical tumor, polyp or cervical cancer
5. Patient diagnosed with uterine fibroid, congenital anomalies in female genital tract, tubercular endometritis, congenital adrenal hyperplasia.
6. Patients that are HIV/VDRL/HbsAg positive.
7. Participants with evidence or history of significant systemic, immunological, gynaecological disorder. (People with hypothyroidism who are on adequate and stable thyroid replacement will not be excluded).
8. Any participant who is not able to give adequate informed consent.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Number of patients achieving a composite score of 0 (indicative of the absence of symptoms and signs associated with PCOS) at the end of day 30 and day 60
2. Increase in total number of patients with a lower score, indicative of reduction in severity of the disease, for a given subjective parameter at day 30 and day 60.
3. reduction in number of cysts by pelvic USG examination.
|
1. Number of patients achieving a composite score of 0 (indicative of the absence of symptoms and signs associated with PCOS) at the end of day 30 and day 60
2. Increase in total number of patients with a lower score, indicative of reduction in severity of the disease, for a given subjective parameter at day 30 and day 60.
3. reduction in number of cysts by pelvic USG examination.
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Safety evaluation will be done by recording adverse events and severe adverse events during each follow up visit.
2. normalized LH levels and LH/FSH ratio |
At the end of Day 60 |
|
|
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)
|
25/04/2018 |
| 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="1"
Months="2"
Days="15" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
The study will enrol adult married female aged between 18-40 years that have been diagnosed with PCOS. Eligible participants screened in baseline interview (day 0) will be randomized into two groups to be treated with either the test product MJR(F), Yin(PC) and Endobal oil blends or placebo. The baseline interview will collect history, demographics and menstrual cycle characteristics. Haematological investigations such complete blood count (CBC), LH/FSH ratio and pelvic ultrasonography (USG) will be performed. Subjects will be evaluated, graded and scored by an physician for the subjective parameters such as regularity of menses, duration, amount of bleeding and pain experienced during menses. A composite score will be calculated for all patients by adding scores for all the subjective parameters investigated (higher score indicative of severity of the disease). During baseline visit on day 0, eligible subjects will receive the test product or the placebo and instructions on how to apply it, for the study duration. Subjects will be re-evaluated for all subjective parameters during follow-up visits done at interval of every 30 days over the duration of the study. A composite score will be calculated for each patient at each visit. Blood samples will be obtained for hematological investigations and pelvic USG performed at day 0, and day 60. Safety follow-up will be done by recording adverse events by subjects during the follow up visits. |