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Clinical Study To Evaluate The Efficacy Of Dahaprashamana Gana In The Management Of Vasomotor Symptoms In Perimenopause And Menopause

Phase 2
Not yet recruiting
Conditions
Disorders of endocrine glands in diseases classified elsewhere. Ayurveda Condition: RAJONASAH (KEVALAVATA),
Registration Number
CTRI/2021/06/033977
Lead Sponsor
Sri Sri College of Ayurvedic Science and Research Hospital
Brief Summary

Menopause is a transitional phase marking the finale of the reproductive life of a woman. It is associated with complex changes in both physical and psychological aspects. The changes are chiefly classified as vasomotor, psychological, genital and urinary symptoms. Among these, vasomotor symptoms are hallmark of menopause affecting 75% of women and in this 25% are severely affected..Vasomotor symptoms of menopause are characterized by episodes of profuse hot flushes accompanied by sweating, experienced predominantly around the head, neck, chest and upper back. These symptoms are experienced by majority of women during menopausal transition and they are the most common and long lasting symptoms according to many cohort and cross sectional studies.

Following menopause hot flashes are still pervasive and are experienced by 50% to 85% of menopausal women. Study done in group of women living in Asia, the intensity of vasomotor symptoms was 58% of women surveyed in 2013. Among menopausal symptoms, vasomotor symptoms among women range from 30% to 80% and they are affecting quality of life too.

Contemporary science offers hormone therapy to ease menopausal symptoms. Hormone therapy carries increased risk of endometrial & breast cancer, thromboembolic disorders, biliary diseases, dementia, emotional changes. There is an increased rate of discontinuity of HRT among women. It is therefore necessary to introduce safe and effective medications for the management of the same.

The term for menopause in Ayurveda is “*rajo nivruthi*â€. Ayurvedic literature has very little reference available about *rajo nivruthi* or menopause. The age of *rajonivruthi* is said to be around 50 years as per the classics and it is considered as a premonitory sign of jara in women. The vasomotor symptoms clearly indicate the involvement of dominant *pitta* dosha associated with *vata.* Hence a drug that pacifies *pitta* along with *vata* is considered for this study.

*Dahaprashamana gana* which has been explained in Charaka Samhitha Sutra sthana, denotes a group of medicinal plants, which has been indicated as useful in removing *daha* or burning sensation which is a direct manifestation of *Pitta*. The name is derived from the word *daha,* meaning burning sensation or internal heat and prashamana which can be translated as â€pacifyingâ€. The gana contains a total ten drugs grouped together viz; *laaja, chandana , kashmarya, madhuka, sharkara,* *nilotpala, usheera, shariba, guduchi* and *hreebera.*

Detailed Description

Not available

Recruitment & Eligibility

Status
Not Yet Recruiting
Sex
Female
Target Recruitment
30
Inclusion Criteria
  • a)Subjects aged between 40 to 60 years.
  • b)Subjects having vasomotor symptoms in perimenopause and menopause.
Exclusion Criteria
  • a) Subject age less than 40 years and above 60 years b) Hemoglobin less than 8 gram percentage.
  • c) Subject known case of or having history of coagulopathy.
  • d) Subjects with other systemic illness like Diabetes Mellitus, Hypertension, Thyroid irregularities, Cardiac diseases e) Subjects having history of carcinoma/ diagnosed carcinoma f) Any pre- existing psychological disorder.

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Dahaprashamana gana churna is effective in vasomotor symptoms in perimenopause and menopause i.e. their will be reduction in hotflushes, night sweat,palpitation and anxiety1st day, 30th day, 60th day
Secondary Outcome Measures
NameTimeMethod
Vitamin E capsule was proved to be effective in treating vasomotor symptoms, which will be assessed by the scales with vasomotor symptoms1st day,30th day, 60th day

Trial Locations

Locations (1)

Sri Sri College of Ayurvedic Science and Research, Bangalore

🇮🇳

Bangalore, KARNATAKA, India

Sri Sri College of Ayurvedic Science and Research, Bangalore
🇮🇳Bangalore, KARNATAKA, India
Dr Shruti S Patil
Principal investigator
9886269111
shrutivinsun@gmail.com

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