| CTRI Number |
CTRI/2018/04/013438 [Registered on: 24/04/2018] Trial Registered Prospectively |
| Last Modified On: |
09/11/2018 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Crossover Trial |
|
Public Title of Study
|
Effectiveness of topical natural oil blend to treat Primary dysmenorrhea |
|
Scientific Title of Study
|
A randomized, double blind, placebo-controlled, crossover study to evaluate the effectiveness of topical application of Go-Go YIN oil blend on relieving the symptoms of Primary dysmenorrhea |
| Trial Acronym |
|
|
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 |
Clinical Research Room
First Floor
Kanpur Nagar
UTTAR PRADESH
208020
India |
| Phone |
9866330090 |
| Fax |
|
| Email |
jainrashee8@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Anit Singh MD |
| Designation |
Medical Director |
| Affiliation |
Clinical Research Network India |
| Address |
Inox Tower Plot No17 Sec 16 A Noida
Gautam Buddha Nagar
UTTAR PRADESH
201301
India |
| Phone |
9866330090 |
| Fax |
|
| Email |
anitsmd@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Anit Singh MD |
| Designation |
Medical Director |
| Affiliation |
Clinical Research Network India |
| Address |
Inox Tower Plot No17 Sec 16 A Noida
Gautam Buddha Nagar
UTTAR PRADESH
201301
India |
| Phone |
9866330090 |
| Fax |
|
| Email |
anitsmd@gmail.com |
|
|
Source of Monetary or Material Support
|
| Gods Own Store LLP
A-89 Amritpuri (opp. Iskcon Temple)
East of Kailash, New Delhi-110065 India
|
|
|
Primary Sponsor
|
| Name |
GODS OWN STORE |
| Address |
A-89 Amritpuri East of Kailash Delhi |
| 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 Centre |
Clinical Research Room First Floor
Kanpur Nagar
UTTAR PRADESH |
9866330090
jainrashee8@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
Modification(s)
|
| Health Type |
Condition |
| Patients |
Primary dysmenorrhea, (1) ICD-10 Condition: N944||Primary dysmenorrhea, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Go-Go YIN oil |
Natural- plant extract based oil blend
The subjects will be instructed to start applying the product 2 days prior to tentative start of the menstrual cycle and will continue applying twice in morning as well as evening, throughout the period duration |
| Comparator Agent |
Placebo |
blend of Soyabean & Sunflower Oils
The subjects will be instructed to start applying the product 2 days prior to tentative start of the menstrual cycle and will continue applying twice in morning as well as evening, throughout the period duration |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
20.00 Year(s) |
| Gender |
Female |
| Details |
1. Participants must be single females, aged 18-20 years old with regular cycles lasting three to seven days. Subjects must have a negative pregnancy test. Pregnant patients or individual with history of pregnancy will be excluded from the study.
2. Subjects suffering from primary dysmenorrhea with a pain level >5 (severe pain) on a visual analogue scale and are not undergoing treatment for the pain.
3. The menstrual discomfort experienced should not be due to secondary dysmenorrhea and the Subjects should not be suffering from any systemic or gynaecologic disorders.
4. Participants should be willing to sign a written consent for participation in the study and undergo a baseline interview.
5. Participants must be willing to commit to medication dosing and assessment visits for evaluation.
6. Participants must be willing to refrain from taking analgesics from the outset of the study until second phase evaluation (if patient force to take allopathic medicine, subject will be dropped from the study).
7. Participants must agree that during the study they will refrain from taking any new herbal supplement and prescription or non-prescription medications without prior approval of the research team.
8. Participants must agree to take healthy diet and life style |
|
| ExclusionCriteria |
| Details |
1. Participants with known or suspected secondary dysmenorrhea (major abdominal or pelvic surgery, endometriosis, pelvic inflammatory disease (PID), ovarian cysts, pathological vaginal secretion, chronic abdominal pain, inflammatory bowel disease, and irritable bowel syndrome).
2. Single or married subjects who are pregnant or have borne children.
3. Participants with a history of or current any kind of hormonal therapy during the last 6 months.
4. Participants with evidence or history of significant systemic or gynecological disorder. (People with hypothyroidism who are on adequate and stable thyroid replacement will not be excluded).
5. Participants weighing less than 50 kg and malnourished.
6. Patients reporting use of analgesics during the study period.
7. Participant with known allergies to the main components of the test product or placebo.
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. reduction of menstrual cramps and
2. reduction in abdominal/pelvic pain within 30 minutes of the application of Go-Go Yin essential oil blend during the first three days of menstruation as compared to the placebo.
3. Reduction in the duration of menstruation and/or
4. Regulating excessive menstrual bleeding and improve pelvic health.
|
Baseline Visit (Assessment Visit 1) Day 4 menstrual cycle 1
Assessment Visit 2 Day 4, menstrual cycle 2
Assessment Visit 3 Day 4, menstrual cycle 3
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Adverse Events |
Baseline Visit (Assessment Visit 1) Day 4 menstrual cycle 1
Assessment Visit 2 Day 4, menstrual cycle 2
Assessment Visit 3 Day 4, menstrual cycle 3
|
|
|
Target Sample Size
|
Total Sample Size="64"
Sample Size from India="64"
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)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
None Yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
The study will enrol adult female aged between 18-20 years that have been suffering from symptoms of primary dysmenorrhea. Eligible participants screened in baseline interview (assessment visit 1) will be randomized into two groups to be treated with either the test product Go-Go Yin essential oil or placebo. The baseline interview will collect data such as age, age at menarche, length of menstrual cycle, duration of menstrual flow, level and duration of pain, and amount of menstrual bleeding (number of saturated pads). Patients will be evaluated on first, second and third day of the menstrual cycle (assessment visit 2) after the first phase of treatment. Subsequently, for the second phase of treatment, the intervention will be switched between the groups and the subjects will be re-evaluated as before during the next menstrual period (assessment visit 3). Safety analyses will be done at each visit. |