| CTRI Number |
CTRI/2025/01/079601 [Registered on: 27/01/2025] Trial Registered Prospectively |
| Last Modified On: |
21/01/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Unani
Behavioral |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Effect of Black seeds in discomfort during menstruation |
|
Scientific Title of Study
|
Effect of Shuneez in premenstrual syndrome a randomized placebo controlled trial |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Tabassum Bano |
| Designation |
PG scholar |
| Affiliation |
National institute of unani medicine |
| Address |
Opd no 29 National institute of unani medicine kottigepalya main magadi road bangalore 560091
Bangalore
KARNATAKA
560091
India |
| Phone |
09660101073 |
| Fax |
|
| Email |
banot6267@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Wajeeha begum |
| Designation |
Professor |
| Affiliation |
National institute of unani medicine |
| Address |
Opd no 29 National institute of unani medicine kottigepalya main magadi road bangalore 560091
Bangalore
KARNATAKA
560091
India |
| Phone |
9972550185 |
| Fax |
|
| Email |
drwajeehanium@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Wajeeha begum |
| Designation |
Professor |
| Affiliation |
National institute of unani medicine |
| Address |
Opd no 29 National institute of unani medicine kottigepalya main magadi road bangalore 560091
KARNATAKA
560091
India |
| Phone |
9972550185 |
| Fax |
|
| Email |
drwajeehanium@gmail.com |
|
|
Source of Monetary or Material Support
|
| National institute of unani medicine kottigepalya magadi main road bengaluru karnataka india 560091 |
|
|
Primary Sponsor
|
| Name |
National institute of unani medicine |
| Address |
Opd no 29 National institute of unani medicine kottigepalya main magadi road bangalore 560091 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| Dr Tabassum bano |
National institute of unani medicine |
Opd no 29 National institute of unani medicine kottigepalya main magadi road bangalore 560091
Bangalore
KARNATAKA |
09660101073
banot6267@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| National institute of unani medicine |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N943||Premenstrual tension syndrome, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Placebo |
Roasted wheat flour Oraly 2 capsules 500mg per day for 10 days 5 days before menses and 5 days during menses |
| Intervention |
Shuneez |
Shuneez Nigella sativa Linn Powder of Shuneez is prepared as per standard preparation Oraly 2 capsules 500mg per day for 10 days 5 days before menses and 5 days during menses |
|
|
Inclusion Criteria
|
| Age From |
15.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Female |
| Details |
Regular cycle and a cycle length 21 35 days
Symptoms of premenstrual syndrome such as anxiety depression irritability headache confusion insomnia mood swings abdominal bloating breast tenderness fatigue backache menstrual cramps starting from day 14 of previous menstrual cycle to day 1 of current menstrual cycle
|
|
| ExclusionCriteria |
| Details |
Irregular cycle and any abdominal and pelvic pathology
On hormonal replacement therapy oral contraceptives under gone hysterectomy
Uncontrolled diabetes mellitus hypertension thyroid dysfunction
Diagnosed cases of psychiatric disorder
Lactating mother
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Improvement in PMSS, SDS Scales |
0 30 days 60 days 90 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Anxiety irritability depression confusion insomnia mood swings headache breast tenderness, abdominal bloating fatigue backache menstrual cramps |
0 30 days 60days 90days |
|
|
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
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
02/02/2025 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
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
|
Premenstrual syndrome a common cyclic disorder
of young and middle aged women is characterized by emotional and physical
symptoms that consistently occur during the luteal phase of menstrual cycle Women with more severe affective symptoms are classified as having premenstrual
dysphoric disorder This disorder can manifest with a wide variety of symptoms including depression mood lability abdominal pain breast tenderness headache and fatigue Symptoms typically begin between the ages of
25 and 45 years The prevalence of PMS has been reported in 20 to
32 of premenopausal and 30 to 40 of the reproductive female population Premenstrual
syndrome is one of the most common disorder of reproductive age that can be
seen in different intensities in 85-90 and about 5 of women experience severe symptoms that the symptoms
interfere with their daily activities Nigella sativa shuneez kalonji has been considered
for trial having mudirr i bawl wa hayd muhallil riyah musakkin muqqawi
meda mullayan taba dafe nafakh shikam musakkin dard e shikam dafe istiskah
etc Also it possesses many properties like immunopotentiation and
antihistaminic antidiabetic anti hypertensive anti inflammatory and
antimicrobial activities It is easily available cost effective and having
less side effects Hence it has been selected to evaluate the effect in PMS
|
Several scales are used to determine the
level of severity as well as the diagnosis of PMS The development of the
Premenstrual Syndrome Scale PMSS was based on DSM III and DSM IV R and is
a reliable scale for measuring the severity of premenstrual symptoms The
Sheehan Disability Scale SDS was originally designed to assess functional
impairment associated with anxiety disorder
|
Shuneez Kalonji Nigella sativa has antiviral antioxidant anti inflammatory immunomodulatory broncho dilatory antihistaminic antitussive activities In
addition it has also shown anti hypertensive anti obesity anti diabetic antih yperlipidemic anti ulcer and antineoplastic activities Black seeds have lots of volatile oils that hold
strong anti inflammatory properties which manages abdominal spasm or cramps
linked to menstruation |