Lashuna capsules in psychological complaints of menopausal ladies
- Conditions
- With menopausal symptoms
- Registration Number
- CTRI/2017/10/010204
- Lead Sponsor
- Dr Kavyashree K
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Female
- Target Recruitment
- 30
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.
•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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method menopausal rating scale will be used before and after treatment 30 DAYS
- Secondary Outcome Measures
Name Time Method QUALITY OF LIFE 30 DAYS
Trial Locations
- Locations (1)
Sri Dharmasthala Manjunatheswara college of Ayurveda and Hospital Hassan
🇮🇳Hassan, KARNATAKA, India
Sri Dharmasthala Manjunatheswara college of Ayurveda and Hospital Hassan🇮🇳Hassan, KARNATAKA, IndiaDR KAVYASHREE KPrincipal investigator9481765895kavya.klm@gmail.com