| CTRI Number |
CTRI/2025/02/081003 [Registered on: 20/02/2025] Trial Registered Prospectively |
| Last Modified On: |
19/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Unani |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Asarun versus Sumbul ul teeb in Premenstrual symptoms associated with menstraution |
|
Scientific Title of Study
|
Efficacy of Asarun versus Sumbul ul teeb in Premenstrual Syndrome- A randomised clinical study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DrNimra Irfan |
| Designation |
PG Scholar |
| Affiliation |
National Institute of Unani Medicine |
| Address |
OPD 29,National Institute of Unani Medicine, Kottigepalya, Magadi main road, Bangalore
Bangalore
KARNATAKA
560091
India |
| Phone |
7389524689 |
| Fax |
|
| Email |
nimrairfan6102@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Kouser Fathima Firdous |
| Designation |
Assisstant professor |
| Affiliation |
National Institute of Unani Medicine |
| Address |
OPD 29,National Institute of Unani Medicine, Kottigepalya, Magadi main road, Bangalore
Bangalore
KARNATAKA
560091
India |
| Phone |
9743730208 |
| Fax |
|
| Email |
kouser2fathima@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Kouser Fathima Firdous |
| Designation |
Assisstant professor |
| Affiliation |
National Institute of Unani Medicine |
| Address |
OPD 29,National Institute of Unani Medicine, Kottigepalya, Magadi main road, Bangalore
Bangalore
KARNATAKA
560091
India |
| Phone |
9743730208 |
| Fax |
|
| Email |
kouser2fathima@gmail.com |
|
|
Source of Monetary or Material Support
|
| National Institute of Unani Medicine, Kottigepalya, Magadi main road, Bangalore,Karnataka,India
560091 |
|
|
Primary Sponsor
|
| Name |
National Institute of Unani Medicine |
| Address |
National Institute of Unani Medicine, Kottigepalya, Magadi main 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 Nimra Irfan |
National Institute of Unani Medicine |
OPD 29, Ilmul Qabalat wa Amraz e Niswan,National Institute of Unani Medicine,Kottigepalya,Magadi main road, Bangalore,560091
Bangalore
KARNATAKA |
7389524689
nimrairfan6102@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee |
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 |
| Intervention |
Asarun |
Asarun 3 gm daily orally in 2 divided doses from 15 day prior to the expected menstrual cycle
for 3 consequent cycles |
| Comparator Agent |
Sumbul-ut-teeb |
Sumbul-ut-teeb 4 gm daily orally in 2 divided doses from 15 days prior to the expected menstrual cycle for 3 consequent cycles |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Female |
| Details |
Patients aged between 18 and 35 years.
Having a regular menstrual cycle with a cycle length of 21-35 days.
Presenting with symptoms of premenstrual syndrome (diagnosed by ACOG criteria).
Having a minimum PMTS score more than 17 and VAS score more than 4.
|
|
| ExclusionCriteria |
| Details |
Patients with any organic pelvic pathology,Use of hormonal therapy or oral contraceptives in past 3 months,A known systemic or metabolic disease (Thyroid disease, Diabetes mellitus,
Hypertension).
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reduction in PMTS Score |
Follow up will be done monthly for 3 consecutive cycles during the trial and once after the completion of trial. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Reduction in VAS Score |
Follow up will be done monthly for 3 consecutive cycles during the trial and once after the completion of trial |
|
|
Target Sample Size
|
Total Sample Size="64"
Sample Size from India="64"
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)
|
05/03/2025 |
| 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
|
The National Institute of Mental Health definition states that premenstrual changes or the cyclic occurrence of symptoms that are of sufficient severity to interfere with some aspects of life and which appear with consistent and predictable relationships to menses.PMS is characterized by a group of physical, emotional, and psychological symptoms of varying severity starting a week before the onset of menstruation and ends after the onset of menstruation.Worldwide prevalence of PMS is about 80%-90%,and that in India ranges from 14.3%-74.4%.The aetiology of PMS is unclear hence, definitive treatment is not available. However, several possible treatments have been established based on symptomatic relief .Current treatment options for PMS, which include Selective Serotonin Reuptake Inhibitors (SSRIs) and hormonal therapy are limited, both in terms of their efficacy and associated side effects often only partially alleviating symptoms. It is estimated that up to 80% of the worlds population rely on herbal medicines as a primary source of healthcare and traditional medical practice and some of these medicinal plants have been shown to be effective in relieving PMS symptoms.The ancient physicians mentioned that, ImtilÄi kaifiat exist in the premenstrual phase which leads to number of features like anxiety, headache, irritability, insomnia, decreased concentration, palpitations etc.It is well studied that surge of AkhlÄt-i-Muharrika (hormones) are responsible for the accumulation of body fluid in tissue spaces during premenstrual phase and this theory correlates with the concept given by IbnSina and others.Several unani drugs like Mushktramashi, Sumbul-ut-teeb, Parsiyawashan, Asarun, Anisoon, Zanjabeel, Zafran, Baboona, Gouzaban, Asgandh, Methi, Qust etc which possess properties Muharrik-i-asab, Muqawwi-i-asab, Munaqi-i-asab, Muqawwi-i-dimagh, Munaqi-i-dimagh, Mudirr-i-bawl, Mudirr-i-haiz, Muqawwi-i-gurda, Muqawwi-i-mida, Mufatteh sudad, Muhallil-i-awarm, Mulattif, Musakkin, Muqawwi-i-jigar, Mulayyin-i-shikam, Qabid activities and are described to overcome the various symptoms associated with PMS.Of these Asarun is selected to evaluate its effect in comparison with Sumbul-ut-teeb in the management of PMS. |