An ayurvedic medicine with yoga in premenstual psychological issues

Completed

• Conditions: Other depressive episodes. Ayurveda Condition: ARutava saMbandha viShada,

• Registration Number: CTRI/2023/06/054584
• Lead Sponsor: Jancy K S

Brief Summary

Five percent of women have severe premenstrual symptoms and impairment of functioning defined as premenstrual dysphoric disorder (PMDD). The burden of illness of PMDD includes disruption of parenting and partner relationships and decreased productivity in work roles. In addition, women with PMDD have increased use of health care services such as clinician visits and increased use of medications. The aetiology of PMDD is multifactorial. In particular, dysregulation of the serotonin and allopregnanolone systems is implicated. Several effective treatment options exist, including serotonergic antidepressant medications and an oral contraceptive that contains ethinyl estradiol and drosperinone. In addition, other hormones that suppress ovulation, anxiolytics, cognitive therapy, and calcium  supplementation  are reported as helpful.  Several women report weight gain and sexual dysfunction after long-term antidepressant and hormonal use for PMDD

PMDD is listed in the *Diagnostic and Statistical Manual of Mental Disorders, 5th Edition* (DSM-5) as a separate entity under Depressive disorders. *Kaly**Änaka ghá¹›ta is* a formulation from Ayurvedic classics used in psychiatric diseases and also observed as effective in reproductive domain. It is mentioned by *Aacaarya Vaagbhat’a* in *Unmaada prathishedha.* Previous studies have pointed out the use of *Kaly**Änaka ghá¹›ta for* *Snehapana* in Depressive disorder.

The holistic approach of yoga by considering ‘mind-body’ interactions makes it an effective and acceptable approach to manage stress and improve the quality of life. Previous studies point out effect of *yoga* in premenstrual symptoms.The purpose of the proposed study is to evaluate the role of  *yoga* protocol and *KalyÄnaka ghá¹›ta* in PMDD and quality of life.               16 participants satisfying the inclusion criteria will be administered *Kaly**Änaka ghá¹›ta* with the selected *yoga* protocol for 2 menstrual cycles and effect will be assessed with the assessment tools.The data will be analysed with adequate statistical tests.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-10-07
• Study Completion: 2024-05-23
• Last Update Posted: 2024-09-19

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 16

Inclusion Criteria

• Subjects fulfilling the diagnostic criteria for premenstrual dysphoric disorder as per DSM 5.
• •Moderate to severe PMDD by – Premenstrual symptom screening tool (PSST).
• •Women in the age group of 18 – 40 yrs.
• •Women with regular menstrual cycle (28 ±7) [14] for the last 3 months.
• •Those fit for snehana and yoga.
• •Those who provide informed consent.

Exclusion Criteria

•Those with history of psychiatric illness / on psychiatric medication •Those with known pelvic pathologies •Known cases of Cardio vascular diseases, Chronic hepatic diseases, Renal dysfunction, Thyroid dysfunction, Hyperlipidemia, Hypertension •Lactating women •Women on oral contraceptives and hormonal therapy.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
2.The data compiled using Premenstrual tension observer rating scale, Premenstrual symptom screening tool, Sheehan disability scale, Q-LES-Q-SF questionnaire Investigations.	1.Participants advised to report on 1st,30th,60th,90th day | 2.The data compiled using Premenstrual tension observer rating scale, Premenstrual symptom screening tool, Sheehan disability scale, Q-LES-Q-SF questionnaire Investigations.
4. asseesing the mental and physical health of participants	1.Participants advised to report on 1st,30th,60th,90th day | 2.The data compiled using Premenstrual tension observer rating scale, Premenstrual symptom screening tool, Sheehan disability scale, Q-LES-Q-SF questionnaire Investigations.
1.Participants advised to report on 1st,30th,60th,90th day	1.Participants advised to report on 1st,30th,60th,90th day | 2.The data compiled using Premenstrual tension observer rating scale, Premenstrual symptom screening tool, Sheehan disability scale, Q-LES-Q-SF questionnaire Investigations.

Trial Locations

Locations (1)

Vaidyaratnam PS Varier Ayurveda Hospital kottakkal; 🇮🇳 Malappuram, KERALA, India

Vaidyaratnam PS Varier Ayurveda Hospital kottakkal

🇮🇳Malappuram, KERALA, India

Jancy K S

Principal investigator

08547490836

jancyksurendran@gmail.com