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CTRI Number  CTRI/2019/03/018232 [Registered on: 22/03/2019] Trial Registered Prospectively
Last Modified On: 20/03/2019
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Unani 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Unani formulation in Pelvic Inflammatory Disease 
Scientific Title of Study   Efficacy of Unani formulation in Pelvic Inflammatory Disease-A randomised standard controlled 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  Fatima Jabeen 
Designation  PG Scholar  
Affiliation  National institute of Unani medicine  
Address  Girls hostel unit 2 National institute of Unani medicine kottegepalya magadi main road Banglore 560091
Dept. of Ilmul Qabalat wa Amraze Niswan National institute of Unani medicine kottegepalya magadi main road Banglore 560091
Bangalore
KARNATAKA
560091
India 
Phone  7827613363  
Fax    
Email  akansaree@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Wajeeha Begum 
Designation  Professor department of OBG 
Affiliation  National institute of Unani medicine  
Address  National institute of Unani medicine kottegepalya magadi main road Banglore 560091
National institute of Unani medicine kottegepalya magadi main road Banglore 560091
Bangalore
KARNATAKA
560091
India 
Phone  9972550185  
Fax    
Email  drwajeehanium@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Wajeeha Begum 
Designation  Professor department of OBG 
Affiliation  National institute of Unani medicine  
Address  National institute of Unani medicine kottegepalya magadi main road Banglore 560091
National institute of Unani medicine kottegepalya magadi main road Banglore 560091

KARNATAKA
560091
India 
Phone  9972550185  
Fax    
Email  drwajeehanium@gmail.com  
 
Source of Monetary or Material Support  
National institute of Unani medicine kottigepalya, magadi main road 
 
Primary Sponsor  
Name  National institute of Unani medicine 
Address  Department of OBG National institute of Unani medicine kottigepalya magadi main road Banglore Karnataka  
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 
Fatima Jabeen  National institute of Unani medicine   OBG OPD 32 Kottigepalya Magadi Main Road Bangalore
Bangalore
KARNATAKA 		 7827613363

akansaree@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
IEC-NIUM  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: N74||Female pelvic inflammatory disorders in diseases classified elsewhere, (2) ICD-10 Condition: N74||Female pelvic inflammatory disorders in diseases classified elsewhere,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Khatmi(Althea officinalis Linn), Enabus sa’lab(Solanum nigrum Linn),Maghze tukhme tarbooz(Citrullus vulgaris),Khaksi(Sisymbrium irio Linn),Benafsha(Viola odorata Linn) In Sharbat form  Luaab khatmi-3 gms, sheera enabus sa’lab-4 gms,sheera maghze tukhme tarbooz-6gms, mix in sharbat banafsha 20 ml & khaksi-4 gms chidak kar, orally 20ml two doses per day FOR 14 days 
Comparator Agent  Tab.Metrogyl 400mg Cap.Doxicyclin 100mg  Tab Metrogyl 400 mg thrice and Tab Doxicyclin100 mg twice daily for 14 days. 
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  40.00 Year(s)
Gender  Female 
Details  Married women age group of 20-40 years
Mild to moderate PID as per CDC Criteria (CDC diagnostic criteria i.e. pelvic
or lower abdominal pain and uterine / adnexal or cervical motion tenderness and
more than or equal to 1 of its minor criteria i.e. fever(101 degree F), abnormal cervical or vaginal
mucopurulent discharge, abundant number of WBC on wet mount test of vaginal fluid, elevated ESR or CRP, positive test for cervical infection with N.
gonorrhoea or C. trachomatis include in this criteria)
Medical diagnosis of uncomplicated pelvic inflammatory disease(Sub-acute
PID with mild to moderate signs and symtoms) 
 
ExclusionCriteria 
Details  Severe PID and its Complications
Pregnant and lactating women
Systemic illnesses and malignancies
A history of uterine or pelvic or abdominal surgery and less than 30days before treatment 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Not Applicable 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
change in subjective parameters.  before and after treatment 
 
Secondary Outcome  
Outcome  TimePoints 
change in objective parameters  before and after treatment 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
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)   25/03/2019 
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   None yet 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary   Pelvic Inflammatory disease is a major health problem of reproductive age women in both developed and developing countries.the actual burden of the disease is unknown but the data from the USA suggests that > 10 %of women of reproductive age have a history of PID. Pelvic inflammatory disease is one o the serious infection facing women today. The sequelae of the PID including tubal infertility, ectopic pregnancy and chronic pelvic pain, other sequelae like tubo-ovarian abscess and pelvic adhesions. An early and accurate diagnosis of PID is of paramount importance for the effective management of the acute illness and for the long term sequelae. Natural ,herbal or traditional medicine is now been seen with an  eye of great interest and hope. So it has been decided to conduct a clinical trial with an objective to evaluate the efficacy of Unani formulation in PID. 
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