Effect of aniseed in menopausal symptoms in women
- Conditions
- Other symptoms and signs involvingthe genitourinary system,
- Registration Number
- CTRI/2022/02/039961
- Lead Sponsor
- National Institute of Unani Medicine
- Brief Summary
Clinical manifestations associated with *IḥtibÄsal-Ṭamth* such fatigue, loss of appetite, weight gain, hirsutism,headache, backache, neck pain, general myalgia, arthralgia, nervousness,anxiety, depression, and insomnia has been described in Unani classical texts,that is probable analogue with menopausal symptoms. InUnani medicine, single and compound drugs are useful to relieve the menopausalsymptoms which are similar to the *SawdÄwá¿‘AmrÄd*suchas *JoshÄndah-i-AftimÅ«n, HalaylaSiyÄh, KhÄrkhasak, Sumbul al-T**á¿‘b, AslusÅ«s,MÌ’Ì’aÌ’Ì’jÅ«nNajÄḥ, Itrá¿‘falZamÄná¿‘, MÌ’Ì’aÌ’Ì’jÅ«n LanÄ.**2TukhmeAnisoon* (*Pimpinella anisum*L. seeds) inmenopausal women with psychological and other symptoms is effective as itpossesses *Mudirr-i-Ḥayá¸, Muḥallil, Kasir-i-Riyah, MusakhkhinAuzaa,* and *Mufattiḥ*properties. Hence, useful in*SawdÄwá¿‘AmrÄd*(*MalankhÅ«lia*)*, á¹¢udÄ*(headache), *Nafkh al-Shikam* (flatulence)*,*and*KhafaqÄnBÄrid*.7It has alsobeen proven for antidepressant, antioxidant, anticonvulsant,analgesic and anti-inflammatory properties. A study showed that *Anisoon* is well tolerated and effective in reducing vasomotor symptoms of menopause. To evaluate the effect of *Anisoon* in menopausalwomen with psychological and other menopausal symptoms. Diagnosed cases willbe randomly allocated either to the test (n=30) or control group (n=30) andwritten informed consent will be obtained. Patients and PG scholars will beblinded for the study. Orally, in the test group,*Anisoon* will be administered for 8 weeks. In the controlgroup, a placebo will be given. Depression Anxiety and Stress Scale(DASS-21),ModifiedKupperman Index(MKI) and Menopause SymptomsTreatment Satisfaction Questionnaire (MS-TSQ)will used to assess psychological and other menopausal symptomsrespectively.The efficacy of the test drugs will be assessedby DASS-21 self-assessmentquestionnaire for depression, anxiety and stress, Modified Kupperman Indexquestionnaire
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Female
- Target Recruitment
- 60
- Women aged 40 to 60 years.
- Women who either postmenopausal for ≥12 months or peri-menopausal (with amenorrhea lasting 2 to 11 months in the preceding year) will be included.
- Peri-menopausal women ≥ 40 years old and had no other demonstrable reason for their amenorrhea.4 Women with psychological menopausal symptoms as per Depression Anxiety and Stress Scale(DASS-21 scale).
- Women with other menopausal symptoms such as vasomotor and somatic symptoms as per Modified Kupperman Index.
- Diagnosed cases of major depressive disorder, bipolar disorder, panic and phobic disorder, etc.
- Women with known systemic and endocrine diseases like uncontrolled hypertension and uncontrolled diabetes mellitus.
- Women with undiagnosed vaginal bleeding, history of endometrial hyperplasia, rapidly growing leiomyomata, history of surgical menopause.
- Women with hypersensitivity to drugs and past and present history of taking HRT, anxiolytics, antidepressants, mood stabilizers, and sedatives within two months.
- Pregnant and lactating women.
- Women with any kind of malignancies.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change in DASS-21 questionnaire Every month for 4 months
- Secondary Outcome Measures
Name Time Method Change in Modified Kupperman Index questionnaire and change in Menopause Symptoms Treatment Satisfaction Questionnaire (MS-TSQ) Every month for 4 months
Trial Locations
- Locations (1)
National Institute of Unani Medicine
🇮🇳Bangalore, KARNATAKA, India
National Institute of Unani Medicine🇮🇳Bangalore, KARNATAKA, IndiaDr Arfa BegumPrincipal investigator8081880967arfasiddiqui770404@gmail.com