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CTRI Number  CTRI/2022/02/039961 [Registered on: 02/02/2022] Trial Registered Prospectively
Last Modified On: 20/02/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Unani 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   Effect of aniseed in menopausal symptoms in women 
Scientific Title of Study   Effect of Anisoon in Menopausal Women with Psychological Symptoms: A Randomized Placebo-Controlled Study 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Arfa Begum 
Designation  PG scholar 
Affiliation  National Institute of Unani Medicine 
Address  Dept. of Amraze Niswan wa Ilmul Qabalat, National Institute of Unani Medicine, Kottigepalya, Magadi Main Road,

Bangalore
KARNATAKA
560091
India 
Phone  8081880967  
Fax    
Email  arfasiddiqui770404@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Arfa Begum 
Designation  PG scholar 
Affiliation  National Institute of Unani Medicine 
Address  Dept. of Amraze Niswan wa Ilmul Qabalat, National Institute of Unani Medicine, Kottigepalya, Magadi Main Road,

Bangalore
KARNATAKA
560091
India 
Phone  8081880967  
Fax    
Email  arfasiddiqui770404@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Arshiya Sultana 
Designation  Associate Professor 
Affiliation  National Institute of Unani Medicine 
Address  Dept. of Amraze Niswan wa Ilmul Qabalat, National Institute of Unani Medicine, Kottigepalya, Magadi Main Road

Bangalore
KARNATAKA
560091
India 
Phone  9740915911  
Fax    
Email  drarshiya@yahoo.com  
 
Source of Monetary or Material Support  
National Institute of Unani Medicine, Kottigepalya, Magadi Main Road, Bangalore 
 
Primary Sponsor  
Name  National Institute of Unani Medicine 
Address  Kottigepalya, Magadi Main Bangalore, Karnataka 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Arfa Begum  National Institute of Unani Medicine  Room No. 29, Dept of Ilmul Qabalat wa Amraze Niswan, Kottigepalya, Magadi Main Road
Bangalore
KARNATAKA 		 8081880967

arfasiddiqui770404@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional ethical committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: R398||Other symptoms and signs involvingthe genitourinary system,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Placebo  roasted rice flour. Dose and duration same as the test drug 
Intervention  Tukhme Anisoon  Four grams, in two divided doses twice daily, in capsule will be administered orally for 8 weeks 
 
Inclusion Criteria  
Age From  40.00 Year(s)
Age To  60.00 Year(s)
Gender  Female 
Details  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
 
 
ExclusionCriteria 
Details  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
 
 
Method of Generating Random Sequence   Permuted block randomization, fixed 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
Change in DASS-21 questionnaire   Every month for 4 months 
 
Secondary Outcome  
Outcome  TimePoints 
Change in Modified Kupperman Index questionnaire and change in Menopause Symptoms Treatment Satisfaction Questionnaire (MS-TSQ)  Every month for 4 months 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" 
Phase of Trial   N/A 
Date of First Enrollment (India)   07/02/2022 
Date of Study Completion (India) Date Missing 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   Nil 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary   Clinical manifestations associated with Iḥtibās al-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.  In Unani medicine, single and compound drugs are useful to relieve the menopausal symptoms which are similar to the Sawdāwá¿‘Amrādsuch as Joshāndah-i-AftimÅ«n, HalaylaSiyāh, Khārkhasak, Sumbul al-Tá¿‘b, AslusÅ«s, MÌ’Ì’aÌ’Ì’jÅ«nNajāḥ, Itrá¿‘falZamāná¿‘, MÌ’Ì’aÌ’Ì’jÅ«n Lanā.2TukhmeAnisoon (Pimpinella anisumL. seeds) in menopausal women with psychological and other symptoms is effective as it possesses Mudirr-i-Ḥayḍ, Muḥallil, Kasir-i-Riyah, MusakhkhinAuzaa, and Mufattiḥ properties. Hence, useful inSawdāwá¿‘Amrād(MalankhÅ«lia), á¹¢udā(headache), Nafkh al- Shikam (flatulence),andKhafaqānBārid.7It has also been 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 menopausal women with psychological and other menopausal symptoms. Diagnosed cases will be randomly allocated either to the test (n=30) or control group (n=30) and written informed consent will be obtained. Patients and PG scholars will be blinded for the study. Orally, in the test  group,Anisoon will be administered for 8 weeks. In the control group, a placebo will be given. Depression Anxiety and Stress Scale(DASS-21),Modified Kupperman Index(MKI) and Menopause Symptoms Treatment Satisfaction Questionnaire (MS-TSQ)will used to assess psychological and other menopausal symptoms respectively.The efficacy of the test drugs will be assessed by DASS-21 self-assessment questionnaire for depression, anxiety and stress, Modified Kupperman Index questionnaire

 
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