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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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmDrugOther 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.

 
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