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CTRI Number  CTRI/2017/10/010204 [Registered on: 25/10/2017] Trial Registered Retrospectively
Last Modified On: 25/10/2017
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda
Preventive 
Study Design  Single Arm Study 
Public Title of Study   Lashuna capsules in psychological complaints of menopausal ladies 
Scientific Title of Study   An exploratory study on lashuna capsules in psychological complaints of menopausal transition 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Kavyashree 
Designation  PG Scholar 
Affiliation  Sri Dharmasthala Manjunatheshwara College of Ayurveda And Hospital 
Address  Dept of manovigyan evum manasa roga OPD No:5 Sri Dharmasthala Manjunatheswara College of Ayurveda and Hospital Hassan

Hassan
KARNATAKA
573201
India 
Phone  9481765895  
Fax    
Email  kavya.klm@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Kavyashree 
Designation  PG SCHOLAR 
Affiliation  Sri Dharmasthala Manjunatheshwara College of Ayurveda And Hospital 
Address  Dept of Manovigyan evum Manasa roga OPD Num: 5 Sri Dharmasthala manjunatheswara college of ayurveda and hospital hassan karnataka

Hassan
KARNATAKA
573201
India 
Phone  9481765895  
Fax    
Email  kavya.klm@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Savitha HP 
Designation  Associate Professor 
Affiliation  Sri Dharmasthala Manjunatheshwara College of Ayurveda And Hospital 
Address  Dept of Manovigyan evum Manasa roga OPD Num: 5 Sri Dharmasthala manjunatheswara college of ayurveda and hospital hassan karnataka

Hassan
KARNATAKA
573201
India 
Phone  9980168208  
Fax    
Email  savithem@gmail.com  
 
Source of Monetary or Material Support  
Sri Dharmasthala Manjunatheshwara College of ayurveda and hospital , hassan 
 
Primary Sponsor  
Name  Dr Kavyashree K 
Address  Sri Dharmasthala Manjunatheshwara College of Ayurveda & Hospital Thanniruhalla Hassan Karnataka  
Type of Sponsor  Private medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
Sri Dharmasthala Manjunatheshwara College of Ayurveda Hospital Hassan  Sri Dharmasthala Manjunatheshwara College of Ayurveda & Hospital Thanniruhalla Hassan  
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
DR KAVYASHREE K  Sri Dharmasthala Manjunatheswara college of Ayurveda and Hospital Hassan  OPD number 5 Department of Manovigyan evum Manasa Roga Sri Dharmasthala Manjunatheshwara College of Ayurveda & Hospital Hassan
Hassan
KARNATAKA 
9481765895

kavya.klm@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICS COMMITTEE  No Objection Certificate 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  With menopausal symptoms,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Lashuna capsules  patients who will fix into the inclusion criteria will be included for study and will be given lashuna capsules for 30 days. 
Comparator Agent  not applicable  not applicable 
 
Inclusion Criteria  
Age From  45.00 Year(s)
Age To  55.00 Year(s)
Gender  Female 
Details  1 Age group between 45-55years
2 Subjects under menopausal transition having
irregular menstrual cycles
3 Patients who have not undergone Hormone
Replacement Therapy
4 Subjects diagnosed based on above diagnostic
criteria and mainly who have psychological
manifestations during this phase
 
 
ExclusionCriteria 
Details  • Patients with a history of psychiatric illness and alcoholics
• Patients who had surgical menopause
• Patients with severe gastritis, gastric ulcer
• Patients having menorrhagia
• Patients having major organic pathology of reproductive system like carcinoma, fibroid cyst etc.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
menopausal rating scale will be used before and after treatment  30 DAYS 
 
Secondary Outcome  
Outcome  TimePoints 
QUALITY OF LIFE  30 DAYS 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
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   Phase 3/ Phase 4 
Date of First Enrollment (India)   01/01/2017 
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="11"
Days="1" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   NOT YET 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  

According to a survey study conducted by Indian menopause society the number of menopausal woman in India is about 43 million and estimated menopausal population will be 103 million in 2026.  Average age of menopause is 47.5 years in Indian women. Menopausal transition is a period which represent the passage from reproductive to non-reproductive life called as Perimenopause. It has been speculated that some women might be particularly vulnerable to changes in mood and behaviour due to intense hormonal fluctuations leading to alteration in several neurotransmitters.  Prevalence of psychological and somatic symptoms is seen in 80% of women at perimenopausal period. Some of the women may be asymptomatic or may have minimal symptoms or the symptoms may go unnoticed. The psychological complaints experienced by females in perimenopausal age group flare up due to other social factors like familial issues, adjustment problems with adolescent children, feeling of unworthiness and other emotional stressors. Systemic illnesses contribute to the worsening of problem.   Hence there is an acute need to address the mental health status of this age group. Lashuna (Allium sativum) is said to be the best rasayana for females. Moreover it is best vatahara which is aggravated during menopausal transition. Many studies have been conducted on Lashuna to know its Neuro- protective, Anti- cancerous, Cardio protective, Anti-microbial activity. Hence an exploratory study will be conducted to assess the action of lashuna on psychological complaints menopausal transition. The current study will be open labeled single arm (uncontrolled) exploratory clinical trial at outpatient department and inpatient department level in psychological complaints during menopausal transition conducted in Ayurveda teaching hospital located in district headquarter in Southern India. The current study will be involving 30 patients who are selected based on diagnostic and Inclusion criteria and screened by using Menopause Rating Scale. Lashuna capsules will be given for a period of 30 days and relief from subjective symptoms will be assessed on 15th day and on the last day of treatment. Results will be analysed using various statistical tests.

 
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