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CTRI Number  CTRI/2015/02/005544 [Registered on: 16/02/2015] Trial Registered Retrospectively
Last Modified On: 03/12/2018
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Unani 
Study Design  Single Arm Study 
Public Title of Study   To evaluate the Safety and efficacy of Unani formulation in the treatment of Intestinal Worms 
Scientific Title of Study   Clinical Validation of Unani Pharmacopoeial Formulation Qurs-e-DÄ«dān in DÄ«dān al-Am‘ā’ (Intestinal Worms) 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
DA/IW/QD CLNVAL/CCRUM /13-14   Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  PROF S SHAKIR JAMIL  
Designation  DIRECTOR GENERAL 
Affiliation  Central Council for Research in Unani Medicine (CCRUM) 
Address  Central Council for Research in Unani Medicine (CCRUM), Jawahar Lal Nehru Bhartiya Chikitsa Evam Homoeopathy Anusandhan Bhawan, 61-65, Institutional Area, Opp. D Block, Janakpuri

West
DELHI
110058
India 
Phone  01128521981  
Fax  01128522965  
Email  unanimedicine@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  DR K M SIDDIQUI  
Designation  DEPUTY DIRECTOR 
Affiliation  Central Council for Research in Unani Medicine (CCRUM) 
Address  Central Council for Research in Unani Medicine (CCRUM), Jawahar Lal Nehru Bhartiya Chikitsa Evam Homoeopathy Anusandhan Bhawan, 61-65, Institutional Area, Opp. D Block, Janakpuri

West
DELHI
110058
India 
Phone  01128521981  
Fax  01128522965  
Email  ccrum507@gmail.com  
 
Details of Contact Person
Public Query  
Name  DR PRADEEP KUMAR  
Designation  RESEARCH OFFICER SCIENTIST III  
Affiliation  Central Council for Research in Unani Medicine (CCRUM) 
Address  Central Council for Research in Unani Medicine (CCRUM), Jawahar Lal Nehru Bhartiya Chikitsa Evam Homoeopathy Anusandhan Bhawan, 61-65, Institutional Area, Opp. D Block, Janakpuri

West
DELHI
110058
India 
Phone  01128521981  
Fax  01128522965  
Email  drpradeepkumar2001@gmail.com  
 
Source of Monetary or Material Support  
Infrastructural support : 1. Central Research Institute of Unani Medicine (CRIUM), Lucknow 2. Regional Research Institute of Unani Medicine (RRIUM), Bhadrak 3. Regional Research Institute of Unani Medicine (RRIUM), Kolkata 4. Clinical Research Unit (CRU), Bhopal 
 
Primary Sponsor  
Name  Central Council for Research in Unani Medicine CCRUM New Delhi  
Address  Jawahar Lal Nehru Bhartiya Chikitsa Evam Homoeopathy Anusandhan Bhawan, 61-65, Institutional Area, Opp. D Block, Janakpuri,New Delhi-110058. 
Type of Sponsor  Research institution 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NA 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 4  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
DR Mohammad Arshad II  Central Research Institute of Unani Medicine (CRIUM), Lucknow   C-39, Jankipuram,P.O., Sector-C ,Terhi Puliya, Kursi Road, Lucknow- 226021
Lucknow
UTTAR PRADESH 		 05222361720
05222732088
crium_lko@yahoo.co.in 
DR AMIR FAISAL   Clinical Research Unit (CRU), Bhopal  Department of Pharmacology, Ghandhi Medical College
Bhopal
MADHYA PRADESH 		 09827082483

dramir_faisal@yahoo.in 
DR SYED ABDULLAH HUSSANI  Regional Research Institute of Unani Medicine (RRIUM), Bhadrak  CHANDBALI BYE-PASS ROAD
Bhadrak
ORISSA 		 09437436408

drhakim077@gmail.com 
DR MOHAMMAD NAWAB  Regional Research Institute of Unani Medicine (RRIUM), Kolkata  79, CHITRANJAN AVENUE, KOLKATA
Kolkata
WEST BENGAL 		 09716402651

drnawab20022000@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 4  
Name of Committee  Approval Status 
Central Research Institute of Unani Medicine (CRIUM), Lucknow   Approved 
Clinical Research Unit (CRU), Bhopal  Submittted/Under Review 
Regional Research Institute of Unani Medicine (RRIUM), Bhadrak  Approved 
Regional Research Institute of Unani Medicine (RRIUM), Kolkata  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied
Modification(s)  
Health Type  Condition 
Patients  DÄ«dān al-Am‘ā’ (Intestinal Worms) , (1) ICD-10 Condition: B820||Intestinal helminthiasis, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  nil  nil 
Intervention  Qurs-e-DÄ«dān  Qurs-e-DÄ«dān ONE TABLET (250 mg) TWICE DAILY BEFORE MEALS WITH WATER for two weeks 
 
Inclusion Criteria  
Age From  10.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  • Patients of either sex in the age group of 10-60 years
• Patients of Dīdān al-Am‘ā’ (intestinal worms) with and without any of the following signs & symptoms:
 Ikhrāj-i-Dīdān (Passage of worms in stool)
 Waja‘ al-Batn Mutakarrar (Recurrent Abdominal Pain)
 Nafkh al-Batn (Abdominal Bloating)
 Hikka al-Maq‘ad Laylī (Nocturnal Perianal Itching)
 Sarīr al-Asnān (Odontoprisis)
 Kasrat-i-Ifrāz Lu‘āb-i-Dahan (Water Brash especially in the morning hours)
 
 
ExclusionCriteria 
Details  • Known cases of cardiac, hepatic or renal ailments
• Patients having history of adverse reaction to any ingredient of the study drug.
• Patients on long-term medication
• Patients taking Vitamin C, B-Complex and Iron preparations
 
 
Method of Generating Random Sequence    
Method of Concealment    
Blinding/Masking    
Primary Outcome  
Outcome  TimePoints 
Improvement in signs and symptoms of DÄ«dān al-Am‘ā’ (Intestinal Worms)   2 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
Haematological and biochemical assessment for safety assessment   2 weeks 
 
Target Sample Size   Total Sample Size="300"
Sample Size from India="300" 
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)   01/01/2014 
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="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   nil 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary   This study is designed as a multicentric open trial in patients with DÄ«dān al-Am‘ā’ (Intestinal Worms). After screening, Patients will be enrolled if they satisfy inclusion and exclusion criteria. The patients will be assessed clinically every week. This includes subjective assessment of general well being and physical examination . The total duration of treatment will be two weeks. . Laboratory parameters for safety assessment will be conducted at baseline and end of study.  
 

Composition of Qurs-e-Dīdān

S. No.

Ingredients

Botanical / Zoological Name

Quantity

1.

Palaspapra Muqashshar

Butea monosperma

1 Part

2.

Maghz-e-Tukhm-e-Karanj

Pongamia pinnata

1 Part

3.

Nankhwah

Ptycotis ajowan

1 Part

4.

Qimbeel

Mallotus philippensis

1 Part

5.

Baobarang

Embelia ribes

1 Part

6.

Turbud

Operculina turpethum

1 Part

7.

Qand Siyah

Saccharum officinarum

1 Part

 
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