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
|
|
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. |