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CTRI Number  CTRI/2025/08/093251 [Registered on: 19/08/2025] Trial Registered Prospectively
Last Modified On: 19/08/2025
Post Graduate Thesis  No 
Type of Trial  PMS 
Type of Study   Ayurveda 
Study Design  Single Arm Study 
Public Title of Study   Menstrua Care Lotion to help reduce period pain, white discharge and excessive bleeding. 
Scientific Title of Study   A Retrospective Analysis of the Data from the Focus Group - Non-Randomised, Single Arm, Non-Comparative, Open Label, Proof of Concept study conducted on Menstura Care Lotion of Nanic Wellness Pvt. Ltd. in Menstruating Females to Regulate Menstrual Cycle, Control Leucorrhea, Regulate Excessive Menstruation and Reduce Dysmenorhea. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
YB/GYN/001/25 Version 01 dated 21Jul25  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr VT Sriraam 
Designation  Chief Trial Coordinator 
Affiliation  Yellow Bricks Research Hub 
Address  Unit of Aurous HealthCare R&D India Pvt. Ltd. Room No 1, Research and Development Department No 128, Shakthi Flats, NTR Garden Street, Rangarajapuram Main Road, Kodambakkam

Chennai
TAMIL NADU
600024
India 
Phone  9840909155  
Fax    
Email  md@auroushealthcare.com  
 
Details of Contact Person
Scientific Query  
Name  Dr VT Sriraam 
Designation  Chief Trial Coordinator 
Affiliation  Yellow Bricks Research Hub 
Address  Unit of Aurous HealthCare R&D India Pvt. Ltd. Room No 1, Research and Development Department No 128, Shakthi Flats, NTR Garden Street, Rangarajapuram Main Road, Kodambakkam

Chennai
TAMIL NADU
600024
India 
Phone  9840909155  
Fax    
Email  md@auroushealthcare.com  
 
Details of Contact Person
Public Query  
Name  Dr VT Sriraam 
Designation  Chief Trial Coordinator 
Affiliation  Yellow Bricks Research Hub 
Address  Unit of Aurous HealthCare R&D India Pvt. Ltd. Room No 1, Research and Development Department No 128, Shakthi Flats, NTR Garden Street, Rangarajapuram Main Road, Kodambakkam

Chennai
TAMIL NADU
600024
India 
Phone  9840909155  
Fax    
Email  md@auroushealthcare.com  
 
Source of Monetary or Material Support  
Nanic Wellness Pvt. Ltd. No-3, Sathy Main Road, Kovilpalayam, Coimbatore-641107 Tamil Nadu, India 
 
Primary Sponsor  
Name  Nanic Wellness Pvt Ltd 
Address  No-3, Sathy Main Road, Kovilpalayam, Coimbatore-641107 Tamil Nadu, India 
Type of Sponsor  Pharmaceutical industry-Indian 
 
Details of Secondary Sponsor  
Name  Address 
Yellow Bricks Research Hub  Room No1, Research and Development Department, Unit of Aurous HealthCare R&D India Pvt. Ltd. No 128, Shakthi Flats, NTR Garden Street, Rangarajapuram Main Road, Kodambakkam 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Arun Kumar  Nanic Wellness Pvt. Ltd.  No-3, Sathy Main Road, Kovilpalayam, Coimbatore-641107
Coimbatore
TAMIL NADU 		 9788888388

nanicayurveda@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Universal Ethics Committee (A Unit of Aurous HealtCare Research and Development India Pvt. Ltd )  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:N946||Dysmenorrhea, unspecified. Ayurveda Condition: UDAVARTINI, (2) ICD-10 Condition:N921||Excessive and frequent menstruation with irregular cycle. Ayurveda Condition: ARTAVAKSHAYAH, (3) ICD-10 Condition:N921||Excessive and frequent menstruation with irregular cycle. Ayurveda Condition: ASRUGDARAH/RAKTAPRADARAH, (4) ICD-10 Condition:N898||Other specified noninflammatory disorders of vagina. Ayurveda Condition: YONIROGAH/YONI-VYAPADAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmDrugOther than Classical(1) Medicine Name: Menstura Care Lotion, Reference: NA, Route: Topical, Dosage Form: Malahara/ Ointment/ Balm, Dose: 1(g), Frequency: od, Bhaishajya Kal: Antarabhakta, Duration: 3 Months, anupAna/sahapAna: No, Additional Information: Menstura Care Lotion is an ayurvedic medicine to be used to regulate Menstrual cycle, control Leucorrhea, regulate excessive menstruation and reduce dysmenorhea. Dose : 1g/day Dosage : Everyday at night for three menstrual cycles. Instructions : Apply Menstura Care Lotion on the navel and massage in clockwise direction
2Comparator Arm (Non Ayurveda)-NoneNon Comparative , Single Arm Study
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  55.00 Year(s)
Gender  Female 
Details  1. Subjects who were willing to use Menstura Care Lotion to regulate Menstrual cycle, control Leucorrhea, regulate excessive menstruation and reduce dysmenorhea.
2. Subjects willing to give informed consent.
3. Subjects willing to give feedback of their own free will 
 
ExclusionCriteria 
Details  1. Subjects who could not give feedback for three menstrual cycles.
2. Subjects with known hypersensitivity to product ingredients. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
1. Numerical Rating Scale : Pain : Reduction in pain levels.
2. Numerical Rating Scale : Bleeding Intensity : Reduction in bleeding intensity
3. Numerical Rating Scale : White Discharge : Reduction in discharge
4. Cycle Length : Reduction in cycle length
5. Feedback Treatment : Excellent response.
 		 Baseline
End of Cycle 1
End of Cycle 2
End of Cycle 3 
 
Secondary Outcome  
Outcome  TimePoints 
NIL  NIL 
 
Target Sample Size   Total Sample Size="39"
Sample Size from India="39" 
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)   29/08/2025 
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="3"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
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   Study Design : Retrospective Analysis of Data from Focus Group - Non Randomised, Single Arm, Non-Comparative, Open Label, Proof of Concept Study
Indication :
1. To Regulate Menstrual Cycle
2. To Control Leucorrhea
3. To Regulate Excessive Menstruation
4. To Reduce Dysmenorrhea
Investigational Product : Menstura Care Lotion of Nanic Wellness Pvt. Ltd.
Comparator : None. Not applicable.
Dose : 1g/day
Dosage : 1 OD for 3 menstrual cycles
ROA : Navel application (Nabhi)
Subject Population : Menstruating females willing to provide feedback for three menstrual cycles of their own free will
Number of Subjects : 39 Subjects
Treatment Arm : Single Arm
Assessments 
1. Numerical Rating Scale  - Pain
2. Numerical Rating Scale - Bleeding Intensity
3. Numerical Rating Scale  - White Discharge
4. Cycle Length
5. Feedback of Product
Background of Study : 
Menstrual health disorders such as irregular menstrual cycles, premenstrual symptoms (PMS), and leucorrhea are common among women and can significantly impact their physical, emotional, and social well-being. Menstura Care Lotion, developed by Nanic Wellness Pvt. Ltd., is a topical herbal lotion designed to help with menstrual cycles, ease PMS symptoms, and control leucorrhea.
Purpose of the study : 
Menstruating females were provided with Menstura Care Lotion to help regulate menstrual cycle, reduce leucorrhea, reduce dysmenorrhea. Subjects used the product and provided feedback out of their own free will.
 
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