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CTRI Number  CTRI/2014/09/004997 [Registered on: 10/09/2014] Trial Registered Retrospectively
Last Modified On: 11/12/2019
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Unani
Physiotherapy (Not Including YOGA) 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   Effect of certain unani drugs in stress urinary incotinence in reproductive age women 
Scientific Title of Study   Clinical Evaluation of Stress Urinary Incontinence in Women of Reproductive Age and its Management with Combination of Two Unani Drugs 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Padmaja AR 
Designation  PG scholar 
Affiliation  National Institute of Unani Medicine 
Address  Dept of Amraze Niswan wa Ilmul Qabalat, National Institute of unani Medicine, Magadi Main Road, Kottigepalya
Dr. Arshiya Sultana, Lecturer, Dept. of Amraze Niswan wa Ilmul Qabalat,National Institute of Unani Medicine, Magadi main road, kottigepalya
Bangalore
KARNATAKA
560091
India 
Phone  919740915911  
Fax    
Email  padmajaamruth@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Arshiya Sultana 
Designation  Lecturer, Dept. of Amraze Niswan 
Affiliation  National Institute of Unani Medicine 
Address  Lecturer, Dept. of Amraze Niswan wa Ilmul Qabalat, National Institute of Unani Medicine, Magadi main road, kottigepalya
002, 6&7 Ranganatha Regency, 12th cross, 2MN, Annapoorneshwari, Bangalore, Karnataka
Bangalore
KARNATAKA
560091
India 
Phone  0940915911  
Fax    
Email  drarshiya@yahoo.com  
 
Details of Contact Person
Public Query  
Name  Arshiya Sultana 
Designation  Lecturer, Dept. of Amraze Niswan 
Affiliation  National Institute of Unani Medicine 
Address  Lecturer, Dept. of Amraze Niswan wa Ilmul Qabalat, Magadi main road, kottigepalya
002, 6&7 Ranganatha Regency, 12th cross, 2MN, Annapoorneshwari, Bangalore, Karnataka
Koppal
KARNATAKA
560091
India 
Phone  0940915911  
Fax    
Email  drarshiya@yahoo.com  
 
Source of Monetary or Material Support  
National Institute of Unani Medicine, Under Ministry of Health and family welfare under GOI 
 
Primary Sponsor  
Name  National Institute of Unani Medicine 
Address  Kottigepalya, Magadi Main Road, Bangalore, 560091, Karnataka,India 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Padmaja AR  National Institute of Unani Medicine  Room No.29, Dept of Amraze Niswan (Gynec and Obst) Kottigepalya, Magadi Main Road,Bangalore-560091
Bangalore
KARNATAKA 		 9242137366

padmajaamruth@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional ethical committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  Women with stress urinary incontinence,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  micro crystalline edible cellulose PFMT  orally, 2gm twice daily for eight weeks. Same as given in test group  
Intervention  Oleo-gum-resin Kundur (Boswellia serrata) and root of Nagarmotha (C. scariosus) with PFMT   orally, 2gm twice daily for eight weeks PFMT: each patient of both groups was instructed for specific pelvic-floor exercises and met with the physiotherapist of this Institute for 30-minute training session in visit 1, and at each visit of follow up with the researcher. Patients were advised to perform a set of progressive specific exercises along with Kegel’s exercise daily at home for 12 weeks. Initially, patients were assigned exercises that gave them a general awareness of their pelvic-floor musculature. The first awareness exercise consisted of stopping and starting the flow of urine. Second, an overflow exercise was given that consisted of squeezing the thighs and buttocks together and tightening the abdominal muscles. The purpose of the overflow exercise was to get an overflow of muscle contraction into the pelvic-floor muscles. Third, participants were asked to perform posterior pelvic tilts to increase the strength of their lower abdominal muscles, which are important in supporting the pelvic viscera. Patients were next instructed to perform a pure pelvic-floor contraction (Kegel’s exercises), gradually increasing the frequency and duration of the contraction. This exercise consisted of a voluntary inward and upward contraction or squeeze of the pelvic floor. Twenty contractions four times a day, to as many as 200 contractions per day were advised. The recommended posture to be adopted during the prescribed exercise regimen also varied and included sitting, kneeling, standing, lying down and standing with legs astride 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  55.00 Year(s)
Gender  Female 
Details  Parous women aged 18-55 years. Patients identified having symptom of predominant stress urinary incontinence with or without grade 1, 2 and 3 genital prolapse with Valsalva maneuver. Patients with an average daytime voiding interval >2 h, and nocturnal voiding frequency ≤ 2 per day and a positive cough stress test (supine full bladder) observed on physical examination at visit 1. 
 
ExclusionCriteria 
Details  Patients with systemic and endocrine diseases like asthma, tuberculosis, diabetes mellitus, uncontrolled hypertension etc. Patients with any pelvic pathology, malignancy, fistula, enuresis and continuous leakage of urine and on pharmacological treatment for symptoms of urinary incontinence in preceding one month and continence surgery within 6 months were excluded.Pregnant and lactating women and83patients with obstruction of urethra, cognitive and psychiatric impairment and drug treatment for depression. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
The primary outcome measure was changes in stress test and one hour pad test  At baseline and after 8 weeks (post test) 
 
Secondary Outcome  
Outcome  TimePoints 
The secondary outcome (subjective parameter) was change in quality of life assessed by ICIQ-SF questionnaire  Every 2 weeks during treatment of 8 weeks and once after 4 weeks following treatment for one month 
 
Target Sample Size   Total Sample Size="147"
Sample Size from India="60" 
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="60" 
Phase of Trial   N/A 
Date of First Enrollment (India)   22/03/2012 
Date of Study Completion (India) 05/02/2013 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details
Modification(s)  		 Rangaswamy PA, Sultana A, Rahman K, Nagapattinam S. Efficacy of Boswellia serrata L. and Cyperus scariosus L. plus pelvic floor muscle training in stress incontinence in women of reproductive age. Complementary therapies in clinical practice. 2014 Nov 1;20(4):230-6.  
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary   Stress urinary incontinence (SUI) is a major health problem affects 50% women and also frequently associated with women of childbearing age. It has substantial and important effects on health-related quality of life. The objectives were to assess the efficacy and safety of combination of oleo-gum-resin, kundur (Boswellia serrata) and root of nagarmotha (Cyperus scariosus) plus pelvic floor muscle training (PFMT) in the treatment of SUI in reproductive age women and improvement in their health related quality of life (HRQOL).
A prospective, single-blind, placebo-controlled, randomized clinical trial was conducted from March 2012 to Feb 2013. In the test (n=30) and placebo group (n=30), combination of kundur and nagarmotha (equal quantity), 2 g twice daily plus PFMT and placebo (cellulose) plus PFMT respectively was administered for 8 weeks. The primary outcomes were one hour pad test and cough stress test. The secondary outcome was HRQOL assessed by ICIQ-SF questionnaire. The result of primary outcome was divided into cured, improved and failed. The results were analyzed using parametric and nonparametric with 5% significance.

 
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