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CTRI Number  CTRI/2026/01/100611 [Registered on: 08/01/2026] Trial Registered Prospectively
Last Modified On: 16/04/2026
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Single Arm Study 
Public Title of Study   A Study to Check the Safety and Benefits of Bonduc Nut Capsules for Women with Menopause Problems. 
Scientific Title of Study   An Open-Label, Single-Arm, Single-Center Clinical Study To Evaluate The Safety And Efficacy of Bonduc Nut Capsules in Participants with Menopausal Symptoms 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
CTSRS/2532 Version No 1.0 Dated 11 Nov 2025  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Suguru Vasudha 
Designation  Principal Investigator 
Affiliation  Sri Lakshmi Super Speciality Hospital 
Address  Room number 1, 5th floor clinival research room 301, 3rd Main Rd, near Indane Gas, V B Layout, Old Extension, Krishnarajapuram, Bengaluru, Karnataka.

Bangalore
KARNATAKA
560036
India 
Phone  06364898825  
Fax    
Email  drsuguru.vasudha@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Ms Sathyavathi LM 
Designation  HOD Clinical Operations 
Affiliation  Samahitha Research Solutions 
Address  Clinical Research Unit, No.1204, "Ashva",2nd Floor, 26th Main, Jayanagar 9th Block, Bangalore.

Bangalore
KARNATAKA
560069
India 
Phone  9739001749  
Fax    
Email  satyalm@samahitha.com  
 
Details of Contact Person
Public Query  
Name  Ms Mamatha B Gokavi 
Designation  Project Manager 
Affiliation  Samahitha Research Solutions 
Address  Clinical Research Unit, No.1204, "Ashva",2nd Floor, 26th Main, Jayanagar 9th Block, Bangalore.

Bangalore
KARNATAKA
560069
India 
Phone  06364898825  
Fax    
Email  mamatha@samahitha.com  
 
Source of Monetary or Material Support  
CCFT Laboratories, Mansarovar Indl. Est, Mittal Group, 121b, Baghpat Rd, Inside Vishvakarma Ind. Est, Ext, Shradhapuri Phase 2, Panchli Khurd, Meerut, Uttar Pradesh 250001. 
 
Primary Sponsor  
Name  CCFT Laboratories 
Address  Mansarovar Indl. Est, Mittal Group, 121b, Baghpat Rd, Inside Vishvakarma Ind. Est, Ext, Shradhapuri Phase 2, Panchli Khurd, Meerut, Uttar Pradesh 250001. 
Type of Sponsor  Pharmaceutical industry-Indian 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study
Modification(s)  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Suguru Vasudha  Sri Lakshmi Super Speciality Hospital  Room Number 1, 5th Floor, Clinical Research Room, 301, 3rd Main Road, near Indane Gas, V B Layout, Old Extension, Krishnarajapuram, Bangalore-560036
Bangalore
KARNATAKA 		 06364898825

drsuguru.vasudha@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Pranav Diabetes Center Ethics Committee   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:N951||Menopausal and female climactericstates. Ayurveda Condition: RAJONASAH (KEVALAVATA),  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmDrugClassical(1) Medicine Name: Bonduc Nut Capsules, Reference: NA, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 305(mg), Frequency: od, Bhaishajya Kal: Adhobhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: -), Additional Information: -
 
Inclusion Criteria  
Age From  40.00 Year(s)
Age To  60.00 Year(s)
Gender  Female 
Details  1.Perimenopausal women between 40 to 60 years of age with a history of menopausal symptoms for at least one month within the last one year.
2.Presence of moderate to severe menopausal symptoms like hot flashes night sweats insomnia nervousness mood swings vaginal dryness loss of libido.
3.Able and willing to give written informed consent and comply with the requirements. 
 
ExclusionCriteria 
Details  1.Participants with a history of psychiatric illness.
2.Participants who had surgical menopause.
3.Participants suffering from major systemic illness necessitating long term drug treatment like Rheumatoid arthritis Psycho-Neuro-Endocrinal disorders
4.Participants who are undergoing hormonal replacement therapy.
5.Participants having major organic pathology of the reproductive system like carcinoma fibroid cyst.
6.Participated in another clinical drug trial within 3 months before recruitment.
7.Currently active alcohol or drug abuse or history of alcohol or drug abuse within
24 weeks prior to baseline.
8.Participants with any kind of malignancies. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
1. Change in Menopausal Symptom Severity:
-Change in total Menopausal Rating Scale (MRS) score from Baseline to Day 30.
- Assesses improvement across somatic, psychological, and urogenital symptom domains (e.g., hot flashes, sleep disturbances, mood changes,
vaginal dryness). 		 Screening & Baseline(Day 0)
Follow-up (Day 15 ± 2 days)
End of Study (Day 30 ± 2 days)
 
 
Secondary Outcome  
Outcome  TimePoints 
1. Change in Global Symptom Perception:
- Change in Patient Global Assessment (PGA) score from Baseline to Day 30.
- Evaluates participant-reported overall improvement in menopausal symptoms. 		 Screening & Baseline(Day 0)
Follow-up (Day 15 ± 2 days)
End of Study (Day 30 ± 2 days) 
 
Target Sample Size   Total Sample Size="50"
Sample Size from India="50" 
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" 
Phase of Trial   Phase 3 
Date of First Enrollment (India)   19/01/2026 
Date of Study Completion (India) Date Missing 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="4"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Completed 
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
Modification(s)  

Menopause is a natural physiological stage in women characterized by the permanent cessation of menstruation and is often associated with vasomotor, psychological, and urogenital symptoms that can significantly impair quality of life. Although hormone replacement therapy is effective, its use is limited by safety concerns and contraindications, leading many women to seek non-hormonal alternatives. Botanical therapies used in traditional medicine systems are increasingly being explored for menopausal symptom management. Caesalpinia bonduc (Bonduc nut) has been traditionally used for women’s health and has demonstrated antioxidant, anti-inflammatory, and adaptogenic properties in preclinical studies. Piper nigrum (black pepper) contains piperine, a known bioavailability enhancer with neuromodulatory and antioxidant effects. The present study aims to clinically evaluate the safety and efficacy of Bonduc Nut capsules, a combination of Caesalpinia bonduc and Piper nigrum, in 50 women experiencing menopausal symptoms over a duration of 30 days.

 
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