| CTRI Number |
CTRI/2025/01/079044 [Registered on: 20/01/2025] Trial Registered Prospectively |
| Last Modified On: |
21/12/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Unani |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
To evaluate the effect of Asgand in management of pre menstrual syndrome |
|
Scientific Title of Study
|
Efficacy of Asgand in Premenstrual syndrome: A Self
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 |
Dr Shafiya Roohi |
| Designation |
PG Scholar |
| Affiliation |
Government Unani Medical College and Hospital |
| Address |
Room no G6,Department of Ilmul Qabalath wa amraze niswan,Government Unani Medical College and Hospital
Basaweshwaranagar
Bangalore
KARNATAKA
560079, INDIA
Room no G11,Department of Ilmul Qabalath wa amraze niswan,Government Unani Medical College and Hospital
Basaweshwaranagar
Bangalore
KARNATAKA
560079 ,INDIA
Bangalore
KARNATAKA
560079
India |
| Phone |
7204042918 |
| Fax |
|
| Email |
shafiyaroohi@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Manjula S |
| Designation |
Principal |
| Affiliation |
Government Unani Medical College and Hospital |
| Address |
Department of Ilmul Qabalath wa amraze niswan,Government Unani Medical College and Hospital
Basaweshwaranagar
Bangalore
KARNATAKA
560079, INDIA
Room no G6,Department of Ilmul Qabalath wa amraze niswan,Government Unani Medical College and Hospital
Basaweshwaranagar
Bangalore
KARNATAKA
560079 ,INDIA
Bangalore
KARNATAKA
560079
India |
| Phone |
9731628373 |
| Fax |
|
| Email |
gumcprincipal1975@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shafiya Roohi |
| Designation |
PG Scholar |
| Affiliation |
Government Unani Medical College and Hospital |
| Address |
Room no G11,Department of Ilmul Qabalath wa amraze niswan,Government Unani Medical College and Hospital
Basaweshwaranagar
Bangalore
KARNATAKA
560079, INDIA
Room no G6,Department of Ilmul Qabalath wa amraze niswan,Government Unani Medical College and Hospital
Basaweshwaranagar
Bangalore
KARNATAKA
560079 ,INDIA
Bangalore
KARNATAKA
560079
India |
| Phone |
7204042918 |
| Fax |
|
| Email |
shafiyaroohi@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government Unani Medical College & Hospital ,Dr Siddaiah Puranika Road,Basaveshwaranagara,Bengalauru-560079, Karnataka |
|
|
Primary Sponsor
|
| Name |
Government Unani Medical College & Hospital Bangalore-560079 |
| Address |
Government Unani Medical College and Hospital Dr Siddaiah Puranik Road Basaveshwaranagar Bangalore 560079 |
| 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 |
| Dr Shafiya Roohi |
Government Unani Medical College and Hospital |
Room no G6
Department of Ilmul
Qabalat was Amraze
niswan,Dr Siddaiah
Puranik Road
Basaveshwaranagar
Bangalore
KARNATAKA 560079 India
Bangalore
KARNATAKA |
7204042918
shafiyaroohi@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee (IEC) for Biomedical Research Government Unani Medical College Bangalore |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N943||Premenstrual tension syndrome, (2) ICD-10 Condition: N943||Premenstrual tension syndrome, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Not Applicable |
Not Applicable |
| Intervention |
Sufoof of Asgand |
Sufoof of Asgand will be prepared
according to standard method and filled in capsules of 500 mg. 2 capsules will be administered
orally thrice daily with milk starting from 14 days prior to the expected date of menstruation. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Female |
| Details |
Both married and unmarried patients in the age group of 18 to 35 years with regular menstrual
cycle between 21 to 35 days presenting with symptoms of PMS as per ACOG diagnostic criteria and
PMTS scale score more than 7 |
|
| ExclusionCriteria |
| Details |
Patients with
Systemic illnesses DM, HTN, TD
Organic pelvic pathology, Patient on hormonal therapy in last 3 months ,
H/O Psychological disorders ,
Pregnant and Lactating women |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reduction in PMTS Score |
During treatment 5th day of every cycle for 3 cycles
Post treatment After 1 month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Improvement in SF 12 scale for QoL |
During treatment 5th day of every cycle for 3 cycles
Post treatment After 1 month |
|
|
Target Sample Size
|
Total Sample Size="37"
Sample Size from India="37"
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 |
|
Date of First Enrollment (India)
|
30/01/2025 |
| 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="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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 (PMS) is a common health problem in women, which includes series of psychological and physical symptoms experienced 7 to 14 days before the onset of menses.The American College of Obstetricians and Gynaecologists (ACOG) defined PMS as a clinical condition characterized by the cyclic presence of physical and emotional symptoms unrelated to any organic disease that appear during the 5 days before menses in each of the three prior menstrual cycles and disappear within 4 days of the onset of menses, without recurrence until at least cycle day 13. It is estimated that 85%-90% women of childbearing age may experience physical and mental symptoms before the onset of cycle. According to Unani physicians, imtelayi kaifiyat present in the premenstrual phase causes a variety of symptoms like anxiety, tension, headache, irritability, decreased concentration, depression, mood swings, insomnia, anorexia, palpitation, pelvic pain, backache, numbness in hands and legs. It is well documented that a surge of Akhlat muharrika (hormones) is responsible for the accumulation of body fluid in tissue spaces during the premenstrual period and this theory corresponds to the concept of Ibne Sina.According to conventional systems, causes of PMS are not fully known and there is no cure for PMS, its symptoms can be successfully managed by several medicines. The management of PMS ranges from non-pharmacological treatment which includes Dietary supplementation, Cognitive behavioural therapy, Life style changes and pharmacological treatment like antidepressants, hormonal treatment and symptomatic treatment. As Ibne Sina mentioned that treatment should be based on cause, if the cause is heat (hiddat) and dominance of bile it is best treated by evacuation (istefragh) of bile especially by shahtra and halela and if retention of fluid is the reason, then it is excreted through the skin by using drugs such as samaghe arabi and kateera, and if the cause is the weakness of uterus, then astringent with uterine tonics is advised. As Asgand has the actions of alterative, aphrodisiac, deobstruent, diuretic, narcotic, sedative, uterine tonic, analgesic etc. it has been decided to conduct a clinical study to evaluate the efficacy of Asgand on scientific parameters in patients with PMS. |