A clinical study to evaluate the effciency of indigenous Avaleha formulation in the management of Rajonivrutti lakshnas w.s.r to post menopausal syndrome.

Phase 1

Not yet recruiting

• Conditions: Menopausal and female climactericstates,

• Registration Number: CTRI/2019/10/021722
• Lead Sponsor: Parul Institute of Ayurved

Brief Summary

Menopause means permanent cessation of menstruationat the end of reproductive life due to loss of ovarian follicular activity.  It is the point of time when last & finalmenstruation occurs. The clinical diagnosis is confirmedfollowing stoppage of menstruation(Amenorrhea) for twelve consecutive monthswithout any other pathology. Age at which menopause occurs is geneticallypredetermined.The age of menopause ranges between 45-55 years, average being50years.

According to Sushruta menstruationstarts at the age of 12 years & continuing in regular period (every month)stops at the age of 50 when the body is fully in grip senility.Women are affected in varying degrees by the uncomfortable symptoms that can accompanymenopause such as irregular menstrual cycles, hot flushes, disturbed sleeppatterns, vaginal discomfort, and the emotional difficulties.About 60% ofwomen approaching the age of menopause experience some symptoms due tobiochemical changes taking place within. Symptoms often subsides naturally asthe menopausal years progress .Other women experience symptoms suddenly or veryintensely, and seek medical relief for their debilitating effect. In the Modern medicine HormoneReplacement Therapy(HRT) has been mentioned but there are a lot of riskassociated with HRT like Endometrial cancer,Breast cancer, venousthromboembolic(VTE)disease,Coronary heart disease(CHD),Lipid metabolism,DementiaAlziemer. So it is the need tofind efficient, economic, natural and safer formulation to manage postmenopausal  syndrome.

In this study drugslike Shatavari, Shankhpuspi, Jatamansi,Brahmi Sarpgandha ,Durva, Guduchi,Udumber,Bala, Aswagandha ,Arjun, Asthi shrunkhala and Godanti are taken. These durugshave laghu sinigdhaguna and madhur rasa and sheet virya having Balya,Medhya,Nidrajanan and rasayan properties. With all these drugs we areformulating avalehakalpana.

**AIM**ToEvaluate the efficacy of Indigenous drugs on post menopausal syndrome.(Rajonivruttilakshanas)

**OBJECTIVES**To study in detailrajonivruttilakshanasw.s.r to post menopausal syndrome according to ayurvedicand modern science.

HYPOTHESIS:-  I.           Null hypothesis: Avaleha  formulation of indigenous drugs are noteffective in the management of post-menopausal syndrome.(ie. Rajonivruttilakshanas).

II.  Alternate hypothesis: Avaleha formulation of indigenous drugs are   effectivein the management  of  Post-menopausal syndrome. (RajonivruttiLakshanas).

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2019-10-16
• Study Start: 2019-10-31

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: Female
• Target Recruitment: 40

Inclusion Criteria

Back ache vaginal dryness hot flushes excessive sweating headache mood swings depression sleep disturbance.

Exclusion Criteria

pre mature menopause(before 40 years) any pre-exisiting psychological disorders delayed menopause diabetes mellitus surgical menopause disc problem any systemic disorders.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
improvement in symptoms clinical features of post menopausal syndrome	3 month

Secondary Outcome Measures

Name	Time	Method
improvement in general health	improvement in symptoms

Trial Locations

Locations (1)

Parul Ayurveda Hospital and Khmedas Ayurveda Hospital and Parul Sevashram Hospital; 🇮🇳 Vadodara, GUJARAT, India

Parul Ayurveda Hospital and Khmedas Ayurveda Hospital and Parul Sevashram Hospital

🇮🇳Vadodara, GUJARAT, India

Minakshi singh

Principal investigator

9608398775

minakshisingh943@gmail.com