| CTRI Number |
CTRI/2020/02/023404 [Registered on: 17/02/2020] Trial Registered Prospectively |
| Last Modified On: |
20/02/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Unani |
| Study Design |
Other |
|
Public Title of Study
|
Effect of a Unani treatment in urinary infection. |
|
Scientific Title of Study
|
Efficacy of a Unani pharmacopeial formulation in Waram Majra-i-Bawl in women: A randomized standard controlled study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| not applicable |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DR ARSHIYA SULTANA |
| Designation |
ASSOCIATE PROFESSOR |
| Affiliation |
National Institute of Unani Medicine |
| Address |
Room No. 29, Dept. of Ilmul Qabalat wa Amraze Niswan NATIONAL INSTITUTE OF UNANI MEDICINE,
KOTTIGEPALYA, MAGADI MAIN ROAD
Bangalore
KARNATAKA
560091
India |
| Phone |
9740915911 |
| Fax |
|
| Email |
drarshiya@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR ARSHIYA SULTANA |
| Designation |
ASSOCIATE PROFESSOR |
| Affiliation |
National Institute of Unani Medicine |
| Address |
Room No. 29, Dept. of Ilmul Qabalat wa Amraze Niswan NATIONAL INSTITUTE OF UNANI MEDICINE,
KOTTIGEPALYA, MAGADI MAIN ROAD
Bangalore
KARNATAKA
560091
India |
| Phone |
9740915911 |
| Fax |
|
| Email |
drarshiya@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
DR ARSHIYA SULTANA |
| Designation |
ASSOCIATE PROFESSOR |
| Affiliation |
National Institute of Unani Medicine |
| Address |
Room No. 29, Dept. of Ilmul Qabalat wa Amraze Niswan NATIONAL INSTITUTE OF UNANI MEDICINE,
KOTTIGEPALYA, MAGADI MAIN ROAD
Bangalore
KARNATAKA
560091
India |
| Phone |
9740915911 |
| Fax |
|
| Email |
drarshiya@yahoo.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
National Institute of Unani Mediicne |
| Address |
Kottigepalya, Magadi Main Road |
| 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 Arshiya Sultana |
National Institute of Unani Medicine Hospital |
Room no. 29, Dept. of ilmul Qabalat wa Amraze Niswan, Kottigepalya, Magadi Main Road, Bangalore
Bangalore
KARNATAKA |
9740915911
drarshiya@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N390||Urinary tract infection, site notspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Not applicable |
Not applicable |
| Intervention |
Unani pharmacopeia formulation
Maghze Tukhme Khayarain (Cucumis sativus Linn) 5 daram (17.5g)
Maghze Tukhme Kaddu (Cucurbita maxima) 5 daram (17.5g)
Khurfa (Portulaca oleracea Linn) 4 daram (14g)
Tukhme Khubbazi (Malva sylvestris) 3 daram (10.5g)
Parsiaavashaan (Adiantum capillus Linn) 3 daram (10.5g)
|
The drugs will be pounded, sieved and mixed well to make a homogenous Sufuf. Orally, 3.5g powder with Sharbate Banafsha 25ml will be given twice daily for eight days |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Female |
| Details |
Women diagnosed with clinical features such as Pusht me Dard, Usr al-bawl(dysuria), Bawl al-Dam(haematuria), Salsal al-Bawl(urgency), Hurqa al-Bawl(Burning), Taqtir al-Bawl (dribbling).
Clinical features of uncomplicated urinary tract infection (uUTI) symptom as per UTI Assessment (UTISA) questionnaire. |
|
| ExclusionCriteria |
| Details |
Women aged up to 18 years and over 60 years.
Pregnant and lactating women
Those with complicated UTI such as associated with pyelonephritis, urolithiasis, diabetes, neurological conditions or urinary tract obstructions.
Women who will be catheterised.
Hypersensitivity to nitrofurantoin and impaired renal function
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Change in clinical features (urinary frequency, urgency, dysuria or haematuria) assessed by UTISA questionnaire |
after trial on 9th or 10th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Reduction in Severity (e.g., intensity of pain, urgency, frequency and burning) of uncomplicated UTI.6
2. Improvements in quality of life (as estimated by validated outcomes measures SF-12).
3. Morisky Medication Adherence Scale-4 used to assess compliance with herbal medicine.
|
After trial on 9th or 10 th day |
|
|
Target Sample Size
|
Total Sample Size="10"
Sample Size from India="10"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
20/02/2020 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="8"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
Yet none |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
In Unani medicine,
Waram Majra-i-Bawl (urinary tract infection) described
as an infection that starts in the urinary system which includes Waram
al-Kulya, Waram al-Mathana and Waram
al-Ahlil1which may be considered as similar with clinical findings of urinary
tract infection (UTI), described in conventional
medicine.Antibiotics are the
main stay treatment for acute and recurrent UTI. However, antibiotic resistance is estimated
20% for trimethoprim and cephlosporins and 50% for amoxicillin. Further,
it is predicted that antibiotic resistance will continue to increase. Sometimes
side effects may require treatment to be withdrawn. Once prophylaxis is
discontinued even after extended periods of therapy 50% to 60% of women become
re infected with in three months. Therefore, the need for alternative
therapies for UTI is evident. For centuries plants have been used throughout
the world as drugs and remedies for various diseases.Unani
classical texts and pharmacopeia are enriched with medicines useful in Waram Majra-i-Bawl. Below mentioned compound formulation of Unani pharmacopeia is useful
in Waram Majra-i-Bawl, contains Tukhme Khayarein,
Tukhme Kaddu, Khurfa, Tukhme Khubbazi, and Parsiaavashaan. These plant products possesses Muhallil
al-Waram, Musakkin-i-Alam, Mudirr-i-Bawl, and Dafi‘-i-‘Ufunat properties.Pharmacologically they are proven for antimicrobial and anti-inflammatory
properties. This is a pilot study on ten patients as advised by the ethical committee. |