| CTRI Number |
CTRI/2025/01/079124 [Registered on: 21/01/2025] Trial Registered Prospectively |
| Last Modified On: |
20/01/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Unani |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Effect of Melissa officinalis (Lemon Balm) in Postmenopausal women with symptoms. |
|
Scientific Title of Study
|
Efficacy of Badranjboya in Postmenopausal Syndrome: 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 |
Saman Fatma |
| Designation |
PG scholar |
| Affiliation |
National Institute of Unani Medicine |
| Address |
Room No. 29, OPD, Amraze Niswan Kottigepalya, Magadi Main Road
Bangalore
KARNATAKA
560091
India |
| Phone |
08007473956 |
| Fax |
|
| Email |
samanfatma828@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Saman Fatma |
| Designation |
PG scholar |
| Affiliation |
National Institute of Unani Medicine |
| Address |
Room No. 29, OPD, Amraze Niswan Kottigepalya, Magadi Main Road
KARNATAKA
560091
India |
| Phone |
08007473956 |
| Fax |
|
| Email |
samanfatma828@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Arshiya Sultana |
| Designation |
Professor |
| Affiliation |
National Institute of Unani Medicine |
| Address |
Room No. 29, OPD, Amraze Niswan Kottigepalya, Magadi Main Road
Bangalore
KARNATAKA
560091
India |
| Phone |
09740915911 |
| Fax |
|
| Email |
drarshiya@yahoo.com |
|
|
Source of Monetary or Material Support
|
| National Institute of Unani Medicine,Kottigepalya, Magadi Main Road, Bangalore, Karnataka ,560091 |
|
|
Primary Sponsor
|
| Name |
National Institute of Unani Medicine |
| Address |
Kottigepalya, Magadi Main Road,Bangalore, Karnataka 560091 |
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Prof Dr Arshiya Sultana |
National Institute of Unani Medicine |
Room No. 29, OPD, Amraze Niswan Kottigepalya, Magadi Main Road
Bangalore
KARNATAKA |
09740915911
drarshiya@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| National Institute of Unani Medicine, Institutional Ethics Committee for Biomedical Research |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N951||Menopausal and female climactericstates, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Badranjboya (Melissa officinalis L.) |
The drug will be pounded, sieved and mixed well to make a homogenous powder. Five grams will be administered daily orally for 8 weeks. |
| Comparator Agent |
Placebo |
Five grams will be administered daily orally for 8 weeks. |
|
|
Inclusion Criteria
|
| Age From |
45.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Female |
| Details |
All postmenopausal women (at least 1 year without menstrual cycle) with any postmenopausal symptoms as per Modified Kupperman Index scale (MKI) greater than or equal to 7
Women with Pittsburgh Sleep Quality Index score greater than or equal to 5
Women with psychological menopausal symptoms as per Depression, Anxiety and Stress Scale (DASS-21 scale).
All postmenopausal women with follicle stimulating hormone (FSH) greater than 30 IU/ml.
|
|
| ExclusionCriteria |
| Details |
Women with undiagnosed vaginal bleeding, surgical menopause (bilateral oophorectomy) and malignancies.
Use of hormone therapy or oral contraceptives within two months.
Women with co-morbidities such as uncontrolled hypertension (Stage 2 hypertension more than 140/90 mmHg), uncontrolled diabetes mellitus (FBS more than 130mg/dl or PPBS more than 180 mg/dl or RBS more than 200mg/dl or HbA1c more than 7.00 percent), uncontrolled hypothyroid.
Women with extremely severe psychological menopausal symptoms with DASS-21 scores for Depression more than 28, Anxiety more than 20 and Stress more than 34.
Women with obstructive sleep apnea, restless leg syndrome, parasomnia, substances use such as alcohol or on sleeping pills.
Women with diagnosed psychiatric diseases |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Pre-numbered or coded identical Containers |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Change in Modified Kupperman Index questionnaire |
4, 8, 12 and 16 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Change in DASS-21, PSQI, & Palpitation as per MKI score.
|
At baseline week 8 & 16 weeks
|
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
03/02/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="2"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
The Unani system of medicine there is no precise description of
menopause, it can be discussed under amenorrhea and associated
with age of the natural end of menstruation, which is an enrichment to the
Unani medical system. More than 90 percent of women could have serious
short-term and long-term menopausal syndromes, which include urogenital
(vaginal dryness, sexual dysfunction), psychological (stress, anxiety,
depression), and vasomotor (hot flashes, sweating) symptoms. Menopausal
symptoms have the potential to cause serious mental disease and a
low quality of life. One of the Unani medicines
is Badranjboya (Melissa officinalis L.) in
postmenopausal women is effective as it possesses exhilarant, cardiotonic,
concoctive, resolvent, carminative, stimulant, and sedative properties. Furthermore,
pharmacologically, it has phytoestrogens, antioxidant,
anxiolytic, anti-diabetic, antidepressant, cardioprotective, neuroprotective,
anti-inflammatory, and antithyroidal activities. To date, none
of the studies has determined the efficacy and safety of Badranjboya in
postmenopausal syndrome. Hence, there is a need to conduct a clinical trial to
determine the efficacy and safety of Badranjboya in postmenopausal
syndrome. The hypothesis of the study would Badranjboya
will be effective in post menopausal sydrome at post intervention. Diagnosed cases will be
randomly allocated either to the test or control group and written informed
consent will be obtained. Participants, PG scholars, and analysts will be
blinded to the study. Orally, in the test group, Badranjboya five
grams daily will be administered for 8 weeks. In the control group, a placebo
will be given. Any adverse reaction to drugs such as abdominal pain,
urticaria, itching, nausea, vomiting, headache, fatigue and other unsuspected
side effects will be documented. The appropriate tests will be applied to analyse
the data. Descriptive statistical analysis will be used in the study. Results
on continuous measurements will be presented in mean (SD) and results on the
categorical measurements will be presented in number with a 5 percent level of
significance and 95 percent confidence interval |