| CTRI Number |
CTRI/2021/10/037425 [Registered on: 21/10/2021] Trial Registered Prospectively |
| Last Modified On: |
20/04/2022 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Nutraceutical |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Nutritional gummies in Pre Menstrual Syndrome |
|
Scientific Title of Study
|
Safety and efficacy of Power gummies: That time of the month nutritional gummies in Pre Menstrual Syndrome-A multicentric randomized controlled clinical study. |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| MHC/CT/21-22/013 (Version 1.0. dated, 16th July 2021) |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Tanuja Panchabhai |
| Designation |
Consultant |
| Affiliation |
Lokmanya Medical Research Centre and Hospital |
| Address |
314 B Telco Road Chinchwad
Pune
Pune
MAHARASHTRA
411033
India |
| Phone |
9421885129 |
| Fax |
|
| Email |
drtanuja.panchabhai@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Gayatri Ganu |
| Designation |
Managing Director |
| Affiliation |
Mprex Healthcare Pvt. Ltd. |
| Address |
501 Crossroads Wakad
Pune
MAHARASHTRA
411057
India |
| Phone |
8554912644 |
| Fax |
|
| Email |
gayatri.mbgindia@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Mr Kapil Mittal |
| Designation |
Chief Strategic Officer |
| Affiliation |
Aesthetic Nutrition Pvt. Ltd. |
| Address |
Building No. 61, Second Floor, Bhishma Pitamaha Marg, Defense colony
New Delhi
DELHI
110003
India |
| Phone |
9910666670 |
| Fax |
|
| Email |
cso@powergummies.com |
|
|
Source of Monetary or Material Support
|
| Aesthetic Nutrition Pvt. Ltd
Building No. 61, Second Floor, Bhishma Pitamaha Marg, Defense colony, New Delhi- 110003.
|
|
|
Primary Sponsor
|
| Name |
Aesthetic Nutrition Pvt Ltd |
| Address |
Building No. 61, Second Floor, Bhishma Pitamaha Marg, Defense colony, New Delhi- 110003.
|
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Ninad Naik |
Atharv multispecialty Research center |
Krishna chowk Kirti Nagar New Sanghavi Pune 411027
Pune
MAHARASHTRA |
9422089260
doctorninaad@gmail.com |
| Dr Tanuja Naik |
Lokmanya Medical Research Centre and Hospital |
OPD 2, 4 floor, 314/B Telco Road, Chinchwad
Pune
MAHARASHTRA
411033
India
Pune
MAHARASHTRA |
9421885129
drtanuja.panchabhai@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Institutional Ethics Commitee Lokmanya Medical Research centre |
Approved |
| Institutional Ethics Committee Lokmanya Medical Research Centre |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Pre Menstrual Syndrome |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
CBT therapy |
Counselling about PMS and guidance for lifestyle modifications. |
| Intervention |
PMS Gummies |
2 Gummies a day- 3 days before due date of menstrual cycle, 4 days during cycle and after 3 days of cycle. A total of 10 days. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
1.Patients age within the range of 18 to 40 years
2.Patients with regular/ irregular menstrual cycle with a cycle length of 21-35 days
3.Presenting with signs and symptoms of premenstrual syndrome. Any three of the following-
Irritability
Anxiety
Breast tenderness
Abdominal pain
Headache
Mood swings
Hot flushes
PMS related acne
|
|
| ExclusionCriteria |
| Details |
1.Patients on hormonal replacement therapy
2.Patients with known systemic and metabolic diseases in investigator discretion not proving fit for trial
3.Diagnosed cases of psychiatric disorder
4.Pregnant and lactating mothers
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.Changes in symptom grading on VAS scale (0-10) irritability, anxiety, angry outburst, confusion, social withdrawal, breast tenderness, abdominal pain, headache, gastric disturbances like bloating, constipation, body pain, hot flushes, night sweat, swelling of extremities ,acne etc.
2.Changes in premenstrual tension scale (PMTS) score.
3.Changes in quality of sleep questionnaire score. |
Screening Day, Baseline Day, First assessment- 5-7 days after first menstrual cycle, and Second assessment-5-7 days after second menstrual cycle. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Changes in perceived stress scale score.
2.Changes in antioxidant enzyme glutathione (GSH) levels.
3.Changes in complete blood count and serum iron levels.
4.Changes in score of Menstrual Regulation Behavior Questionnaire.
|
Screening Day, Baseline Day, First assessment- 5-7 days after first menstrual cycle, and Second assessment-5-7 days after second menstrual cycle. |
|
|
Target Sample Size
|
Total Sample Size="90"
Sample Size from India="90"
Final Enrollment numbers achieved (Total)= "91"
Final Enrollment numbers achieved (India)="91" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
23/10/2021 |
| Date of Study Completion (India) |
10/03/2022 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
According to the
findings of the study, treatment with PMS Gummies was more effective than
Cognitive Behavioral Therapy (CBT) and counseling in reducing the overall
severity of physical and emotional PMS symptoms, perceived stress, premenstrual
tension in young women with PMS along with improvement in quality of sleep.
There was significant
reduction in abdominal cramps, breast tenderness, acne and GI symptoms such as
bloating and constipation with the treatment of PMS Gummies in two menstrual
cycles. PMS Gummies treatment led to reduced stress and anxiety level, improved
mood and quality of sleep.
90% subjects in PMS
Gummies group did not require any rescue medication in second menstrual cycle. The
strength of the study was the general representation of women in society as a
study participant. There were university students, working and homemaker young
women participation in this study. This provides pulse of effectiveness of PMS
Gummies in PMS management for young women with wide educational, socio economic
diversity as representation of society.
An intervention like
PMS Gummies having nutritional corrections approach along with herbal extract
fortification could be an effective tool in management of PMS and related
symptoms. The present study confirms safety and effectiveness of PMS Gummies in
management of PMS.
Aesthetic Nutrition
sponsored clinical trial to evaluate safety and efficacy of Power Gummies: That
time of the month gummies in reducing symptoms of pre-menstrual syndrome and
achieving improved quality of life.
|