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CTRI Number  CTRI/2022/09/045468 [Registered on: 13/09/2022] Trial Registered Prospectively
Last Modified On: 08/08/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Nutraceutical 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   Comparative study of KSM66 Ashwagandha (Withania somnifera) in women with Menopausal symptoms  
Scientific Title of Study   Efficacy And Safety of KSM66 Ashwagandha (Withania somnifera) Standardized Root Extract for Treatment of Menopausal symptoms in women: A Prospective, Randomized, Double-Blind, Placebo Controlled Study 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Neelamma Patil 
Designation  Principal Investigator 
Affiliation  B. M. Patil Medical Hospital & Research Center 
Address  B. M. Patil Medical Hospital & Research Center, B. M. Patil Medical college, Solhapur road, Vijayapura, Karnataka

Bijapur
KARNATAKA
586103
India 
Phone  09845068074   
Fax    
Email  neelamma.patil@bldedu.ac.in  
 
Details of Contact Person
Scientific Query  
Name  Dr Neelamma Patil 
Designation  Principal Investigator 
Affiliation  B. M. Patil Medical Hospital & Research Center 
Address  B. M. Patil Medical Hospital & Research Center, B. M. Patil Medical college, Solhapur road, Vijayapura, Karnataka

Bijapur
KARNATAKA
586103
India 
Phone  09845068074   
Fax    
Email  neelamma.patil@bldedu.ac.in  
 
Details of Contact Person
Public Query  
Name  Dr Neelamma Patil 
Designation  Principal Investigator 
Affiliation  B. M. Patil Medical Hospital & Research Center 
Address  B. M. Patil Medical Hospital & Research Center, B. M. Patil Medical college, Solhapur road, Vijayapura, Karnataka

Bijapur
KARNATAKA
586103
India 
Phone  09845068074   
Fax    
Email  neelamma.patil@bldedu.ac.in  
 
Source of Monetary or Material Support  
Ixoreal Biomed Private Limited 
 
Primary Sponsor  
Name  Ixoreal Biomed Private Limited 
Address  5-9-225, Sanali Estate, Abids, Hyderabad - 500001  
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 Neelamma Patil  Shri B. M. Patil Medical hospital & Research center   B. M. Patil Medical Hospital & Research Center, B. M. Patil Medical college, Solhapur road, Vijayapura, Karnataka 586103
Bijapur
KARNATAKA 		 09845068074

neelamma.patil@bldedu.ac.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Shri B. M. Patil Medical college, Vijaypura, Karnataka- 586103  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,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Ashwagandha extract 300 mg (KSM66 capsule)  One capsule contains 300 mg Ashwagandha extract. One capsule to be taken orally with water two times daily for 12 weeks 
Comparator Agent  Capsule identical to study capsule  One capsule contains 300 mg Starch. One capsule to be taken orally with water two times daily for 12 weeks 
 
Inclusion Criteria  
Age From  45.00 Year(s)
Age To  65.00 Year(s)
Gender  Female 
Details  – Menopausal women aged 45 to 65 years with intact uterus and ovaries
– Participants who complained of irregular menstrual cycle in the past 12 months, with a forward or postpone of a cycle more 7 days. At least 2 cycles were missing during the past 12 months, or reported menopause for at least 60 days
– Females with complaints of menopausal symptoms, e.g., hot flash, insomnia, migraine, easy irritation, etc.
– Body mass index 18-35 kg/m2
– Subject who has given written informed consent to participate in the study and understand the nature of the study
– Able to read and write in English or any other vernacular language  
 
ExclusionCriteria 
Details  – Taking any form of herbal extract in the last 3 months before study entry
– On hormone replacement therapy (HRT) for more than 3 months
– Present active medical, surgical, and gynecological problems
– History of drug or alcohol abuse
– Undergone bilateral ovariectomy
– History of breast or cervical carcinoma
– Taking medication that affect bone metabolism, including glucocorticoid, anticonvulsant, and methotrexate
– Clinically relevant cardiovascular, gastrointestinal, hepatic, neurologic, endocrine, hematological, or other major systemic diseases making implementation of the protocol or other interpretation of the study result difficult
– Mental condition rendering the subject unable to understand the nature, scope, and possible consequences of the study
– Evidence of uncooperative attitude, including poor compliance
– Inability to attend follow-up visit
– Subject with any other medical condition (for example uncontrolled infection) that may, in the opinion of the Investigator, interfere with the study objective 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Pre-numbered or coded identical Containers 
Blinding/Masking   Participant, Investigator and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Improvement in the composite score of Menopause Rating Scale (MRS) from baseline to end of therapy.
Scale consisted of 11 items, ranging from no symptoms to very severe symptoms. The total score of the MRS ranges from 0 (asymptomatic) to 44 (highest degree of complaints). The minimal/maximal scores vary between the three dimensions, depending on the number of complaints allocated to the respective dimension of symptoms:
a) Psychological domain: 0 to 16 scoring points
b) Somato-vegetative domain: 0 to 16 points
c) Urogenital domain: 0 to 12 points  		 Baseline, 4 weeks and 12 weeks
 
 
Secondary Outcome  
Outcome  TimePoints 
Menopause Symptoms Treatment Satisfaction Questionnaire (MS-TSQ)   Baseline, 4 weeks and 12 weeks
 
Improvement in Perceived Stress Scale (PSS-10)   Baseline, 4 weeks and 12 weeks 
Improvement in the average hot flash score during 24 hours from baseline to end of the therapy  Baseline, 4 weeks and 12 weeks 
Change in Level of Estradiol from baseline to end of therapy  Baseline, 4 weeks and 12 weeks 
Change in Level of follicle stimulating hormone from baseline to end of therapy  Baseline, 4 weeks and 12 weeks 
Change in Level of luteinizing hormone from baseline to end of therapy  Baseline, 4 weeks and 12 weeks
 
Change in Level of testosterone from baseline to end of therapy  Baseline, 4 weeks and 12 weeks 
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="60" 
Phase of Trial   N/A 
Date of First Enrollment (India)   15/09/2022 
Date of Study Completion (India) 14/03/2024 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   None yet. 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

 

This prospective, randomized, double-blind, placebo-controlled study shall compare the efficacy and safety of extract of KSM66 Ashwagandha (Withania somnifera) with placebo in improving menopausal symptoms in women.

1.      Menopausal women aged 45 to 65 years with intact uterus and ovaries

2.      Participants who complained of irregular menstrual cycle in the past 12 months, with a forward or postpone of a cycle more 7 days. At least 2 cycles were missing during the past 12 months or reported menopause for at least 60 days. Females with complaints of menopausal symptoms, e.g., hot flash, insomnia, migraine, easy irritation, etc.

3.      Those not willing to participate and not literate shall be exclude. Women will be randomized to receive either ashwagandha extract capsule 300 mg two times daily or placebo capsule (identical to ashwagandha capsule) two times daily for 12 weeks.

4.      Assessments shall be done using the Menopause Symptoms Treatment Satisfaction Questionnaire (MS-TSQ) (8-item self-administered questionnaire at the end of every 4 weeks of therapy), Improvement in Perceived Stress Scale (PSS-10) from baseline to end of therapy, Improvement in the average hot flash score during 24 hours from baseline to end of the therapy, Change in Level of Estradiol from baseline to end of therapy, Change in Level of follicle stimulating hormone from baseline to end of therapy, Change in Level of luteinizing hormone from baseline to end of therapy, Change in Level of testosterone from baseline to end of therapy and clinical adverse events over a period of 12 weeks (follow-up visits 4 and 12 weeks)

 

 
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