FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2022/02/040551 [Registered on: 23/02/2022] Trial Registered Prospectively
Last Modified On: 09/03/2023
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 to evaluate the safety and efficacy of KSM-66 Ashwagandha® capsule (300 mg) on Menopause Symptoms  
Scientific Title of Study   A Prospective, Double Blind, Randomized, Parallel, Single-Center, Two-Arm, Placebo Controlled Clinical Study to Assess the Efficacy and Safety of KSM-66 Ashwagandha® capsule (300 mg) on Menopause Symptoms  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Isukapalli Vani 
Designation  Principal Investigator 
Affiliation  Govt. Medical College & Govt. General Hospital (Old RIMSGGH) 
Address  Govt. Medical College & Govt. General Hospital (Old RIMSGGH) Srikakulam-532001, Andhra Pradesh, India

Srikakulam
ANDHRA PRADESH
532001
India 
Phone  7569427836  
Fax    
Email  drivaniggh@yahoo.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Sornaraja Thasma 
Designation  Director Quality Assurance 
Affiliation  ProRelix Services LLP 
Address  102 A/B, 1st Floor, Park Plaza, near State Bank Colony, Karve Nagar, Pune, Maharashtra 411052

Pune
MAHARASHTRA
411052
India 
Phone  8124806366   
Fax    
Email  sthasma@prorelixresearch.com  
 
Details of Contact Person
Public Query  
Name  Mr Sohal Pendse 
Designation  Director Operations 
Affiliation  ProRelix Services LLP 
Address  102 A/B, 1st Floor, Park Plaza, near State Bank Colony, Karve Nagar, Pune, Maharashtra 411052

Pune
MAHARASHTRA
411052
India 
Phone  9890096725   
Fax    
Email  s.pendse@prorelixresearch.com  
 
Source of Monetary or Material Support  
Ixoreal Biomed,Plot No-1057-F2, PBN Center, Road No. 45, Jubilee Hills Hyderabad, Telangana 500033 India 
 
Primary Sponsor  
Name  Ixoreal Biomed 
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  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 Isukapalli Vani  Govt. Medical College & Govt. General Hospital (Old RIMSGGH)   Department of Clinical Research, Research wing, Govt. Medical College & Govt. General Hospital (Old RIMSGGH), Srikakulam-532001, Andhra Pradesh, India
Srikakulam
ANDHRA PRADESH 		 7569427836

drivaniggh@yahoo.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, Govt. Medical College & Govt. General Hospital (Old RIMSGGH)  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Menopause 
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmDrugOther than Classical(1) Medicine Name: KSM-66 Ashwagandha®, Reference: NA, Route: Oral, Dosage Form: Capsules, Dose: 300(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 56 Days, anupAna/sahapAna: Yes(details: 1 capsule after breakfast and 1 capsule after dinner), Additional Information: -
2Comparator ArmDrugOther than Classical(1) Medicine Name: Placebo (Starch), Reference: NA, Route: Oral, Dosage Form: Capsules, Dose: 300(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 56 Days, anupAna/sahapAna: Yes(details: 1 capsule after breakfast and 1 capsule after dinner), Additional Information: -
 
Inclusion Criteria  
Age From  45.00 Year(s)
Age To  55.00 Year(s)
Gender  Female 
Details  1.Adult female subjects of age’s ≥ 45 years and ≤55 years.
2.Female patients with clinical diagnosis of menopaue.
3.Patients who can and willing to provide written Informed Consent.
4.Female patients with BMI 20-30 Kg/m2.
5.Female patients who are having more than 10 Hot Flashes events per week.
6.Female patients willing to follow the procedures as per the study protocol.
7.Female patients who agree to take investigational product till Day 56.
8.Female patients who have not undergone any hormone therapy or antidepressant during the past 3 months before enrolment.
9.Patients having capability of complete compliance and completion of follow-up .
10.Participant / participant’s legally acceptable representative understands and can comply with clinical trial protocol requirements.
 
 
ExclusionCriteria 
Details  1.Female patients Ë‚ 45 years or ˃ 55 years of age.
2.Female patients who are severely anemic.
3.Female patients who had previous treatment with hormonal and bio-identical hormonal therapy
4.Female patients having a history of any bleeding disorders.
5.Female patients having a history or presence of any medical conditions which impacts the quality of life.
6.Female patients with hypersensitivity to study product or placebo.
7.Female patients currently using vitamin or mineral supplements, nutritional supplements and or medical foods estrogen, selective serotonin reuptake inhibitors within 30 days before the commencement of study or during the study.
8.Female patients using prescription medications and/or non-prescription medications for acute medical conditions, semi-acute medical conditions, and weight loss.
9.Female patients who are currently pregnant and breast-feeding.
10.Female patients with current diagnosis or medical history of smoking, alcoholism and drug dependence.
11.Female patients having a history of breast, endometrial, other gynaecological cancer at any time or any other cancer within last 5 years.
12.Female patients who are not willing to take investigational product.
13.Patients with uncontrolled, unstable comorbidities.
14.Patients taking part in any other studies, including macro/micro/any other forms of dietary supplements/multivitamins or disease-specific oral nutrition supplements.
15.Any other condition which the principal investigator thinks may jeopardize the safety of patients with uncontrolled, unstable comorbidities.
16.Patients who had participated in other clinical trials during previous 3 months.
 
 
Method of Generating Random Sequence   Other 
Method of Concealment   Pre-numbered or coded identical Containers 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
Reduction in Menopause Rating Scale score from baseline to the end of study  Baseline, Day 56 
 
Secondary Outcome  
Outcome  TimePoints 
1.Change in Hormonal Parameters (Serum Oestradiol, Progesterone, LH & FSH)
2.Changes in Hot Flashes event between Baseline and Day 56
3.Change in SF 12 (Quality of Life) score from baseline
4.Patient’s Global Assessment of Tolerability to Therapy (PGATT)
PSS-10
5.Severity of AEs between groups.
6.Frequency of AEs between groups.
 		 Baseline, Day 56 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
Final Enrollment numbers achieved (Total)= "60"
Final Enrollment numbers achieved (India)="60" 
Phase of Trial   Phase 3 
Date of First Enrollment (India)   28/02/2022 
Date of Study Completion (India) 30/11/2022 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="3"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   Not Applicable 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  

Sixty female adults diagnosed with menopause, aged between 45 to 55 years of age (both inclusive) will be included in this study. There will be total 02 site visits and 01 telephonic interview during the study.

On screening/baseline visit, written informed consent will be obtained from subjects for their participation in the study. Subject’s history will be recorded and her physical examinations will be done. Subject will be recruited in the study if she meets all the inclusion criteria. Subjects will undergo general and systemic examinations. At baseline visit and end of treatment visit, subjects will be provided with diary card to record daily symptoms. Symptoms will be assessed and graded on clinical symptom scoring scale. All subjects will be advised to continue their routine diet and physical activities.

During the study, Subject will be advised to consume 300 mg of Ashwagandha Formulation Twice daily orally after food with a glass of water or milk for 56 days. The investigator on each visit will also assess drug compliance.

Subjects will be called to the study centre on Baseline & 56 the day from the baseline visit. On every physical visit, subjects will undergo general and systemic examinations and assessment of clinical symptoms will be done.  There will be a telephonic follow-up visit on Day 28 to check IP and Protocol Compliance along with the AE detail collection.

Subjects will be contacted telephonically on Day 28 (Visit 2). They will be enquired about adverse events and concomitant medication. Dosing compliance will also be checked and recorded.

  Subjects will be randomized to either one of the two treatment arms. Subjects will be instructed to take the one capsule of study medication to which they are randomized, twice a day after breakfast and dinner, with ambient temperature water for 56 consecutive days at home.

Adverse events and concomitant medication will be recorded throughout the study.

 
Close