| CTRI Number |
CTRI/2018/02/012193 [Registered on: 27/02/2018] Trial Registered Retrospectively |
| Last Modified On: |
28/01/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Unani |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
To observe the effect of unani medicine in patients having little flow during periods. |
|
Scientific Title of Study
|
Effect Of Unani Formulation in Oligomenorrhoea - An Observational Study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Nasreen Aklaque |
| Designation |
PG Scholar |
| Affiliation |
National Institute Of Unani Medicine |
| Address |
Boys Hostel Unit2
National Institute Of Unani Mdicine Kottigepalya Magadi Main Road Bangalore Karnataka
Bangalore
KARNATAKA
560091
India |
| Phone |
9838836783 |
| Fax |
|
| Email |
dr.nasreenaklaque474@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Wajeeha Begum |
| Designation |
Reader and HoD Dept. Of OBG |
| Affiliation |
National Institute Of Unani Medicine |
| Address |
National Institute Of Unani Medicine Kottigepalya Magadi Main Road Banglore KARNATAKA
Bangalore
KARNATAKA
560091
India |
| Phone |
9972550185 |
| Fax |
|
| Email |
drwajeehanium@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Wajeeha Begum |
| Designation |
Reader and HoD Dept. Of OBG |
| Affiliation |
National Institute Of Unani Medicine |
| Address |
National institute Of Unani Medicine Kottigepalya Magadi Main Road Banglore KARNATAKA
Bangalore
KARNATAKA
560091
India |
| Phone |
9972550185 |
| Fax |
|
| Email |
drwajeehanium@gmail.com |
|
|
Source of Monetary or Material Support
|
| National Institute Of Unani Medicine |
|
|
Primary Sponsor
|
| Name |
National Institute Of Unani Medicine |
| Address |
Dept Of OBG Of National Institute Of Unani Medicine
Kottigepalya Magadi Main Road Bangalore KARNATAKA |
| 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 |
| Nasreen Aklaque |
National Institute Of Unani Medicine |
OBG OPD 32 Kottigepalya Magadi Main Road Banglore
Bangalore
KARNATAKA |
9838836783
dr.nasreenakhlaque474@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC-NIUM |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N915||Oligomenorrhea, unspecified, Oligomenorrhoea, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
COMMIPHORA MYRRHA-3gm, JUNIPAROUS COMMUNIS-1gm, RUTA GRAVEOLENS-3gm, RUBIA CARDIFOLIA-3gm SHARBAT BAZOORI-50ml |
decoction of 10 gm unani formulation with 50 ml of sharbat buzoori will be given from 14th day of the menstrual cycle till 14 day for 2 cycles. |
| Comparator Agent |
NOT APPLICABLE |
NOT APPLICABLE |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
Infrequent menstruation of more than 35days or scanty flow both in amount and duration,
Hypothyroidism on treatment & PCOD.
|
|
| ExclusionCriteria |
| Details |
Patients with hyperprolactinaemia,Uterine synechiae, endometrial tuberculosis, ovarian tumours & malignancy,Hypertension, Diabetes mellitus & other systemic diseases,Pregnant women, lactating women and women on IUCDs.
|
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
Changes in Menstrual pattern:Cycle interval (duration of cycle),Menstruation length (duration of flow)
,No. of pads (amount of flow)
|
BEFORE AND AFTER TREATMENT |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Changes in-PBAC,SF-12 survey to assess QOL.
|
BEFORE AND AFTER TREATMENT |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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)
Modification(s)
|
15/05/2018 |
| 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)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Closed to Recruitment of Participants |
|
Publication Details
|
None yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Oligomenorrhoea can only be defined arbitrarily as one in which the cycle last longer than 35days. Menstruation may be both infrequent & irregular or may be regularly infrequent. Oligomenorrhoea with a prevalence of 12-15.3% in different studies around the world, is one of the most common type of menstrual bleeding disorder. It is estimated that oligomenorrhoea has prevalence of approximately 10.2% among women of reproductive age group. Oligomenorrhoea is often associated with PCOS which is the most common endocrine disorder in women. Anovulation is present in 60% of women with oligomenorrhoea. Hormone imbalances such as anovulation & androgen excess disorders such as PCOS, adrenal hyperplasia, hyperprolactinemia and thyroid function disorders are the most important causes of oligomenorrhoea. Complications caused by oligomenorrhoea such as infertility, low fertility, malignancies, cardiovascular diseases , diabetes mellitus, hirsutism & acne vulgaris result in problems regarding women’s general health & quality of life. Therefore, timely diagnosis & treatment of these disorders are of utmost important. Hormone therapy is the main treatment of oligomenorrhoea in western or conventional medicine, however the result of a study on infertile women with oligomenorrhoea and PCOD revealed that only 25.6 % of them has good compliance to this treatment, although effective but have their own side effects. Therefore there is need for alternate therapy. Several drugs are prescribed for qillate tams in unani system of medicine which can be used for treatment. The drug possessing the properties of musaff-i-khoon, mulattife-i-khoon, mudirr-i- bawl wa haiz, munzij balgham and mufatteh sudad etc. are used and are easily available, safe and cost effective. Hence there is need to evaluate the efficacy of unani formulation in qillate tams. Keeping all these facts in view, it has been decided to conduct a clinical study on qillate tams to evaluate the efficacy of unani formulation |