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CTRI Number  CTRI/2025/01/078901 [Registered on: 17/01/2025] Trial Registered Prospectively
Last Modified On: 17/01/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug
Nutraceutical 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   Effectiveness of single dose of ashwagandha capsule on sexual health in healthy women 
Scientific Title of Study   Efficacy and Safety of Single Dose (600 mg) Ashwagandha Root Extract on Sexual Health in Healthy Women: A Prospective, Randomized, Double-Blind, Placebo-Controlled Study  
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
version 1.0, 02nd Dec 2024  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Ujwala Bardapurkar 
Designation  Principal investigator 
Affiliation  Yash Narsing home 
Address  Yash Narsing home, Ground Floor, 333 kaneri agra road, near dhamankar naka, Bhiwandi.

Thane
MAHARASHTRA
421302
India 
Phone  9822065947  
Fax    
Email  ujwala_bardapurkar@yahoo.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Ujwala Bardapurkar 
Designation  Principal investigator 
Affiliation   
Address  Yash Narsing home, 333 kaneri agra road, near dhamankar naka, Bhiwandi .


MAHARASHTRA
421302
India 
Phone  9822065947  
Fax    
Email  ujwala_bardapurkar@yahoo.com  
 
Details of Contact Person
Public Query  
Name  Dr Ujwala Bardapurkar 
Designation  Principal investigator 
Affiliation   
Address  Yash Narsing home, 333 kaneri agra road, near dhamankar naka, Bhiwandi .


MAHARASHTRA
421302
India 
Phone  9822065947  
Fax    
Email  ujwala_bardapurkar@yahoo.com  
 
Source of Monetary or Material Support  
Ixoreal Biomed Private Limited, 5-9-225, Sanali Estate, Abids, Hydrabad-500001, ph: (91)40-23204385/86/87 India 
 
Primary Sponsor  
Name  Ixoreal Biomed Private Limited 
Address  Plot No-1057-F2, PBN Center, Road No. 45, Jubilee Hills Hyderabad, Telangana 500033 India 
Type of Sponsor  Pharmaceutical industry-Indian 
 
Details of Secondary Sponsor  
Name  Address 
NIL   
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
DrUjwala Bardapurkar  Yash Nursing Home  Yash Nursing Home,Ground floor,OPD no 1,333 kaneri agra road,near dhamankar naka,Bhiwandi
Thane
MAHARASHTRA 		 9822065947

ujwala_bardapurkar@yahoo.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee (IEC) for Biomedical and Health Research  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Female aged between 18 to 55 years  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Identical Placebo capsule  Starch capsule once daily after dinner (at bedtime), with a glass of water for 8 weeks. 
Intervention  KSM-66 Ashwagandha®  white capsule contains 600 mg Ashwagandha root extract powder only once daily after dinner (at bedtime), with a glass of water for 8 weeks 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  55.00 Year(s)
Gender  Female 
Details  1.Female participants between 18 to 55 years of age.
2.Participants with a baseline total score of 1 to 26 on the FSFI.
3.Participants with a baseline total score of 1 to 26 on FSDS.
4.The participants should inform their partner about the study.
5.Her partner should be willing to let her participate in the study.
6.Participants are willing to try to have sexual intercourse regularly.
7.Participants in a stable, monogamous, heterosexual relationship that is secure and communicative, for at least 6 months prior to the Screening Visit.
8.Participant’s partner is expected to be physically present at least 50% of each month.
9.Participants who have used a medically acceptable method of contraception for at least 3 months before the baseline Visit (Visit 1) and continue to use that medically acceptable method of contraception during the trial.
10.Participants who are reliable, honest, compliant, and agree to co-operate with all trial evaluations as well as to be able to perform them as per investigator’s opinion.
11.Participants or LAR can and willing to give meaningful, written informed consent prior to participation in the trial, in accordance with regulatory requirements.
12.Participants having sufficient understanding to communicate effectively with the investigator and are willing to discuss their sexual functioning with the investigative staff.
13.Participants who are willing to have 4 or more attempts of sexual intercourse each month.
 
 
ExclusionCriteria 
Details  1.Participants who are not willing to take an investigational product.
2.Any acute illness which may hamper the study participation as per principal investigator discretion at the time of enrolment.
3.Participants having any clinically significant medical history, medical finding or an on-going medical or psychiatric condition exist which in the opinion of the Investigator could jeopardize the safety of the subject, impact validity of the study results or interfere with the completion of study according to the protocol.
4.Individuals participating in any other studies, including macro/micro/any other forms of dietary supplements/multivitamins or disease-specific oral nutrition supplements (for improving the sexual function during the 3 months prior to study commencement).
5.Participants having a history of hypersensitivity reactions (i.e., allergic or oversensitivity to usual doses).
6.Participants with current alcohol or drug addiction or with a history of drug dependence or abuse within the past one year.
7.Participants who indicate that their sexual partner has inadequately treated sexual problems that could interfere with the Subjects response to treatment.
8.Participants who have entered the menopausal transition or menopause or have had a hysterectomy.
9.Participants with findings of infection, inflammation, undue tenderness, or shrinkage (atrophy) of the female genital organs, at the Screening Visit.
10.Participants who are breastfeeding or have breastfed within the last 6 months prior to the Baseline Visit.
11.Participants who are pregnant or have been pregnant within the last 6 months prior to the Baseline Visit.
12.Participants having primary hypoactive sexual desire.
13.Participants with a history of malignancy.
14.Participants themselves are not planning to get pregnant for next six months.
15.Participants who cannot cooperate to complete the subject records during the study.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Mean change in FSFI scores from Visit 1 (Screening Visit/ Enrolment Visit/ Baseline Visit- Day 1), Visit 2 (Week 2), Visit 3 (Week 4) to Visit 4- End of study (Week 8) in healthy women   Baseline, Week 2, Week 4, Week 8  
 
Secondary Outcome  
Outcome  TimePoints 
Mean change in SSEs from Visit 1 (Screening Visit/ Enrolment Visit/ Baseline Visit- Day 1), Visit 2 (Week 2), Visit 3 (Week 4) to Visit 4- End of study (Week 8) in healthy women   Baseline, Week 2, Week 4, Week 8 
Mean change in FSDS scores from Visit 1 (Screening Visit/ Enrolment Visit/ Baseline Visit- Day 1), Visit 2 (Week 2), Visit 3 (Week 4) to Visit 4- End of study (Week 8) in healthy women   Baseline, Week 2, Week 4, Week 8 
Mean change in serum hormones (Estrogen-E2, Progesterone, FSH, LH, Prolactin, and Testosterone) from Visit 1 (Screening Visit/ Enrolment Visit/ Baseline Visit- Day 1) to Visit 4- End of study (Week 8) in healthy women   Baseline, Week 2, Week 4, Week 8 
Mean change in PSS-10 scores from Visit 1 (Screening Visit/ Enrolment Visit/ Baseline Visit- Day 1), Visit 2 (Week 2), Visit 3 (Week 4) to Visit 4- End of study (Week 8) in healthy women  Baseline, Week 2, Week 4, Week 8 
Mean change in SF-12 scores from Visit 1 (Screening Visit/ Enrolment Visit/ Baseline Visit- Day 1), Visit 2 (Week 2), Visit 3 (Week 4) to Visit 4- End of study (Week 8) in healthy women   Baseline, Week 2, Week 4, Week 8 
Number and proportion of Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Event (TESAE) over 8 weeks treatment period  Baseline, Week 2, Week 4, Week 8 
 
Target Sample Size   Total Sample Size="80"
Sample Size from India="80" 
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   N/A 
Date of First Enrollment (India)   28/01/2025 
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="1"
Months="0"
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  

●       All eligible subjects who meet the Inclusion and Exclusion criteria will be part of the study.

●       Subjects will be informed about the purpose of the study and signed informed consent will be taken.

●       Blood sampling for serum E2, FSH, LH, Prolactin, Testosterone and Progesterone hormone levels will be done at Screening/Baseline Visit and End of Study Visit (Week 8 ± 3).

●       Efficacy assessments mentioned above will be done appropriately during the study.

All Subjects will be followed-up during the study period (Screening /Baseline- Day 1, Week 2 ± 3 days, Week 4 ± 3 days, and Week 8 ± 3 days till the complete course of treatment) 
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