| CTRI Number |
CTRI/2024/11/076658 [Registered on: 12/11/2024] Trial Registered Prospectively |
| Last Modified On: |
09/12/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Clinical Study to Test the Effectiveness of Feminocare Capsule in Reducing Menstrual Pain in Women |
|
Scientific Title of Study
|
Evaluating the Efficacy of Feminocare Capsule in the Management of Primary Dysmenorrhea: A Single-Arm Interventional Clinical Trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr J Hareendran Nair |
| Designation |
Managing Director and Founder |
| Affiliation |
Pankajakasthuri Herbal Research Foundation |
| Address |
Room No 1
Department of Research and Development, Pankajakasthuri Herbal Research Foundation Pankajakasthuri
Ayurveda Medical college Kattakkada Trivandrum
Thiruvananthapuram KERALA 695572 India |
| Phone |
|
| Fax |
|
| Email |
hareendrannair@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Kasthuri Nair A |
| Designation |
Director |
| Affiliation |
Pankajakasthuri Ayurveda Medical college and PG centre |
| Address |
Room No:1
Department of Kaychikitsa, Pankajakasthuri
Ayurveda Medical college and PG centre
Killy
Thiruvananthapuram KERALA 695572 India |
| Phone |
8113851665 |
| Fax |
|
| Email |
dr.kasthurinair@pkhil.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Deepa CR |
| Designation |
Assistant Professor |
| Affiliation |
Pankajakasthuri Ayurveda Medical college and PG centre |
| Address |
Room No 1
Department of Prasuti Tantra and Striroga
Pankajakasthuri Ayurveda Medical college and PG centre
Thiruvananthapuram KERALA 695572 India |
| Phone |
9495954439 |
| Fax |
|
| Email |
drdeepacr.bams@gmail.com |
|
|
Source of Monetary or Material Support
|
| Pankajakasthuri Herbals India Pvt. Ltd, Poovachal, Trivandrum, Kerala, India, Pin:69575 |
|
|
Primary Sponsor
|
| Name |
Pankajakasthuri Herbals India Pvt Ltd |
| Address |
Poovachal
Trivandrum
Kerala
India
Pin: 695575 |
| 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 DEEPA CR |
Pankajakasthuri Ayurveda Medical College & PG Centre |
Room no: 1
Department of Prasuti Tantra & Striroga
Pankajakasthuri
Ayurveda Medical
College & PG Centre,
Killy, Kattakada Thiruvananthapuram KERALA |
9495954439
drdeepacr.bams@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Independent Ethics Committee of Pankajakasthuri Herbal Research Foundation |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:N94||Pain and other conditions associated with female genital organs and menstrual cycle. Ayurveda Condition: UDAVARTINI, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Other than Classical | | (1) Medicine Name: Feminocare Capsule , Reference: NA, Route: Oral, Dosage Form: Capsules, Dose: 400(mg), Frequency: tds, Bhaishajya Kal: Adhobhakta, Duration: 120 Days, anupAna/sahapAna: Yes(details: Luke warm water), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
Females of age group 18-45 years with regular cycles and having Primary dysmenorrhea |
|
| ExclusionCriteria |
| Details |
1. Patients with irregular menstruation
2. Patients with pelvic pathology
3. Patients with dysfunctional uterine bleeding.
4. Patients diagnosed with structural deformity of reproductive system |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Change in the mean pain score value assessed by visual analogue
scale. |
Evaluations will take place during the first menstrual period post-administration and continue at equivalent intervals for a total of three cycles, allowing for the assessment of treatment efficacy over time in the management of primary dysmenorrhea |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Change in associated symptoms -nausea, giddiness, diarrhoea
and vomiting will be assessed |
on 30th day, 60th day, 90th day and 120 day |
|
|
Target Sample Size
|
Total Sample Size="60" Sample Size from India="60"
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
|
Phase 2 |
|
Date of First Enrollment (India)
|
18/11/2024 |
| 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="8" Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Dysmenorrhea is a prevalent menstrual disorder that significantly affects
women’s quality of life and work productivity, characterized by painful
menstruation severe enough to disrupt daily activities. This condition impacts
between 58.2% and 89.5% of women of reproductive age. This study is a
single-arm clinical intervention designed to evaluate the efficacy of the Feminocare
capsule in managing primary dysmenorrhea. A total of 60 female patients aged 18-45
years with primary dysmenorrhea, attending the outpatient department of
Pankajakasthuri Ayurveda Medical College and Hospital in Kattakada,
Thiruvananthapuram, will be enrolled. Data collection will involve a structured
case proforma and the Visual Analogue Scale (VAS) for pain assessment.
Additionally, ultrasonography of the abdomen and pelvis and routine blood
investigations will be conducted to exclude any pelvic pathology. The intervention
will consist of administering Feminocare capsules at a dose of two
tablets three times daily after meals for a period of 120 days.
The primary objective of this study is to assess the efficacy of Feminocare
in reducing pain associated with primary dysmenorrhea. The secondary objective
includes evaluating its effect on related symptoms such as nausea, vomiting,
dizziness, and diarrhea. Inclusion criteria are limited to women aged 18-45
years with regular menstrual cycles and primary dysmenorrhea, while patients
with irregular menstruation, pelvic pathology, dysfunctional uterine bleeding,
or structural deformities of the reproductive system will be excluded. The
primary outcome measure will be the change in the mean pain score assessed by
VAS, while secondary outcomes include changes in associated symptoms such as
nausea, dizziness, diarrhea, and vomiting.
The anticipated outcome is that Feminocare will significantly
reduce both pain levels and associated symptoms in primary dysmenorrhea,
potentially improving the quality of life and functional capacity in affected
women. This study may provide supportive evidence for Feminocare as an
effective therapeutic option for managing primary dysmenorrhea. |