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Study to find out the effect of shirodhara with balaswagandhadi taila,rasayan churna vati and lifestyle modification in post menopausal women

Phase 3
Not yet recruiting
Conditions
Diseases of the genitourinary system, (2) ICD-10 Condition: N952||Postmenopausal atrophic vaginitis. Ayurveda Condition: rajonirvrtti,
Registration Number
CTRI/2022/04/042117
Lead Sponsor
All India Institute Of Ayurveda
Brief Summary

Menopause is one of the most important phases of life of a woman. It is defined as permanent  cessation of menstruation at the end of reproductive life due to loss of ovarian follicular  activity1. It is a natural process that happens to every woman as she grows older and not a  medical problem, disease or illness, even though it may appear so2.

CLASSICAL

According to ayurvedic classics, while describing physiology of menstruation, it is mentioned  that complete cessation of menstruation occurs at the age of 50 years. 6

By this time women in reproductive phase of life having pitta predominance terminates  into the vata phase of life.7It is also mentioned as a kshaya stage of life due to aging process.  Kshaya of dhathus, mainly rasa dhathu will ultimately leads to raja kshaya which is  considered to be the byproduct of the former. Raja itself is a physiological entity which is  having swabhava of degradation and ultimately manifests as rajonirvritti. Diminition of  dhathus will manifests in woman as various anatomical and psychological symptoms and  they are described as menopausal syndrome in modern medical science.

INVESTIGATIONS

A. Routine Blood investigations including CBC, TFT, lipid profile , LFT , KFT , Blood  sugar

B. Urine for routine and microscopic examination

C. Hormonal essay for FSH and LH

D. USG

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GROUPING AND DRUG DELIVERY REGIME

| | | | |

| --- | --- | --- | --- |

|S.NO

Group

Description

Dose & Duration

|1

Group A

Lifestyle modifications.



|2

Group B

1.Rasayan churna vati

2.Lifestyle modifications

3 tablets twice a day with lukewarm  water , daily after meals for 21 days

|3

Group C

1.Abhyanga(Tila taila -15  minutes),swedana(Sarawanga  swedana by Dashamool  kashaya for 5 -7 minutes)  Shirodhara with  Balaswhagandhadi taila.

2.Rasayan churna vati

3.Lifestyle modifications

1) 21 days schedule with 5 days  Shirodhara sessions of 30 minutes with  3 days break in between will be  advocated (i. e 3 cycles of 5 days each).

2) 3 tablets twice a day with lukewarm  water , daily after meals for 21 days.

Lifesstyle modification as per the previous study will be advised to patient and also relatives  and will make sure they are doing it by regular follow up.

FOLLOW UP

At the interval of 2 weeks for 2 months after completion of the treatment.

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WITHDRAWAL CRITERIA

1) If patient is unwilling to continue the selective procedure.

2) If patient is allergic / sensitive to selective procedures.

Detailed Description

Not available

Recruitment & Eligibility

Status
Not Yet Recruiting
Sex
Female
Target Recruitment
90
Inclusion Criteria
  • women who have cessation of menstruation for 1 year or more 2.
  • postmenopausal women with symptoms of menopausal syndrome, who are willing to prticipate in the study.
Exclusion Criteria
  • Postmenopausal women who had previos exposure to therapieseg; yoga and panchakarma procedures taken within 3 months.
  • postmenopausal women who are undergoing hormonal replacement therapy 3.
  • patients suffering from any major illness, eg; cancer, diabetis mellitus,cardiac disorerstuberculosis etc 4.
  • Patients having surgical menopause.

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Impovement in symptoms will be assessed using kupperman index and menopause rating scale21 days
Secondary Outcome Measures
NameTimeMethod
to see change in quality of life of postmenopausal women2 months intervention and 2 months follow up

Trial Locations

Locations (1)

All India Institute Of Ayurveda

🇮🇳

South, DELHI, India

All India Institute Of Ayurveda
🇮🇳South, DELHI, India
Dr Athira k
Principal investigator
9947150302
athirachandran1442@gmail.com

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