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CTRI Number  CTRI/2019/10/021547 [Registered on: 07/10/2019] Trial Registered Prospectively
Last Modified On: 20/09/2021
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   Study the efficacy and safety of Ashwagandha extract in Women with Perimenopausal Symptoms 
Scientific Title of Study   Evaluation of Efficacy and Safety of extract of Ashwagandha (Withania somnifera) Standardized Extract in Women with Perimenopausal Symptoms: A Prospective, Randomized, Double-Blind, Placebo-Controlled Study 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
DYP-PMS-WS-03-2019 Version 1.0 dt. 01-07-2019  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Sriram Gopal 
Designation  Professor & Head 
Affiliation  Dr D Y Patil Medical College, Hospital And Research Center 
Address  Department of Obstetrics and Gynaecology Room No. 60 First floor D Y Patil Hospital Plot 2 sector 5 Nerul Navi Mumbai

Thane
MAHARASHTRA
400706
India 
Phone  02227702218  
Fax    
Email  sriram.gopal@dypatil.edu  
 
Details of Contact Person
Scientific Query  
Name  Deepak Langade 
Designation  Professor and Head, Pharmacology 
Affiliation  Dr D Y Patil Medical College, Hospital And Research Center 
Address  Department of Pharmacology fifth floor Medical College Building D Y Patil Medical College and Hospital Sector-5, Nerul Navi Mumbai Maharashtra INDIA

Thane
MAHARASHTRA
400706
India 
Phone  9930550009  
Fax    
Email  deepak.langade@dypatil.edu  
 
Details of Contact Person
Public Query  
Name  Deepak Langade 
Designation  Professor and Head, Pharmacology 
Affiliation  Dr D Y Patil Medical College, Hospital And Research Center 
Address  Department of Pharmacology fifth floor Medical College Building D Y Patil Medical College and Hospital Sector-5, Nerul Navi Mumbai Maharashtra INDIA

Thane
MAHARASHTRA
400706
India 
Phone  9930550009  
Fax    
Email  deepak.langade@dypatil.edu  
 
Source of Monetary or Material Support  
D Y Patil Medical College and Hopsital Sector 5, Nerul, Navi Mumbai 400706 Maharashtra INDIA 
 
Primary Sponsor  
Name  Dr D Y Patil Medical College Hospital and Research Center 
Address  PLot No. 2, Sector - 5, Nerul, Navi Mumbai 
Type of Sponsor  Private medical college 
 
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 Sriram Gopal  D Y Patil Hospital  Department of Obstetrics and Gynaecology Room No. 60 First floor D Y Patil Hospital Plot 2 sector 5 Nerul Navi Mumbai
Thane
MAHARASHTRA 		 02227709218

sriram.gopal@dypatil.edu 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee (IEC), Padmashree Dr D Y Patil Medical College, Hospital and Research Center, Navi Mumbai  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: N959||Unspecified menopausal and perimenopausal disorder,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Control  Capsule identical to study capsule of Ashwagandha extract containing starch Dose: 1 capsule twice daily orally with water for 8 weeks 
Intervention  Study  Ashwagandha Standardized extract capsule 300 mg Dose: 1 capsule twice daily orally with water for 8 weeks 
 
Inclusion Criteria  
Age From  40.00 Year(s)
Age To  55.00 Year(s)
Gender  Female 
Details  1. Perimenopausal women 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
3. Females with complaints of perimenopausal symptoms, e.g., hot flash, insomnia, migraine, easy irritation, etc.
4. Body mass index 18-35 kg/m2
5. Subject who has given written informed consent to participate in the study and understand the nature of the study
6. Not illiterate
 
 
ExclusionCriteria 
Details  1. Taking any form of herbal extract in the last 3 months before study entry
2. On hormone replacement therapy for more than 3 months
3. Present active medical, surgical and gynecological problems
4. History of drug or alcohol abuse
5. Ovariectomy
6. History of breast or cervical carcinoma
7. Taking medication that affect bone metabolism, including glucocorticoids, anticonvulsant and methotrexate
8. Clinically relevant cardiovascular, gastrointestinal, hepatic, neurologic, endocrine, hematologic or other major systemic diseases making implementation of the protocol or other interpretation of the study result difficult
9. Mental condition rendering the subject unable to understand the nature, scope and possible consequences of the study
10. Evidence of uncooperative attitude, including poor compliance
11. Inability to attend follow-up visit
12. 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 and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Composite score of Menopause Rating Scale (MRS)  Baseline, 4 weeks, 8 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
Composite score of Menopause Specific Quality of Life (MEN-QOL) questionnaire  Baseline, 4 weeks, 8 weeks 
Hot flash score  Baseline, 4 weeks, 8 weeks 
Menstrual Pain  Baseline, 4 weeks, 8 weeks 
Blood pressure (systolic and diastolic)   Baseline, 4 weeks, 8 weeks 
Menstrual cycle  Baseline, 8 weeks 
Waist circumference  Baseline, 4 weeks, 8 weeks 
Serum hormone levels (FSH, LH, Estradiol, Testesterone)  Baseline, 4 weeks, 8 weeks 
Global Assessment of Tolerability to Therapy (PGATT)   End of therapy (8 weeks) 
CLinical adverse events  Baseline, 4 weeks, 8 weeks 
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="100" 
Phase of Trial   N/A 
Date of First Enrollment (India)   14/10/2019 
Date of Study Completion (India) 29/12/2019 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   None 
Individual Participant Data (IPD) Sharing Statement

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

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 perimenopausal symptoms in women. 

Perimenopausal women aged 45 to 60 years of age having a BMI of 18-35 kg/m2, with intact uterus and ovaries who complain of irregular menstrual cycle in the past 12 months, with a forward or postpone of a cycle more 7 days wil be screened for enrollment. Women should have miss at least 2 cycles  during the past 12 months, or reported menopause for at least 60 days. Women may have complaints of perimenopausal symptoms, e.g., hot flash, insomnia, migraine, easy irritation, etc. 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 8 weeks. 

Assessments shall be done using the Menopause Rating Scale (MRS), Menopause Specific Quality of Life (MEN-QOL) questionnaire, menstrual cycle patterns, symptoms, waist circumference, blood pressure, serum hormones (FSH, LH, testesterone, estradiol) and clinical adverse events over a period of 8 weeks (follow-up visits 4 & 8 weeks)

 
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