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CTRI Number  CTRI/2019/02/017801 [Registered on: 25/02/2019] Trial Registered Prospectively
Last Modified On: 21/02/2019
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug
Unani 
Study Design  Single Arm Study 
Public Title of Study   Treatment of Functional Dyspepsia (Indigestion) with Unani medicine Majoone- Sangdana Murgh 
Scientific Title of Study   Clinical Validation of Unani Pharmacopoeial Formulation Majoone-Sangdana Murgh in Du‘f al-Mi‘da (Functional Dyspepsia) 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
DM/FD/MSM/CLNVAL/CCRUM/17-18, Version 1  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Prof Asim Ali Khan 
Designation  Director General 
Affiliation  Central Council for Research in Unani Medicine (CCRUM) 
Address  Jawahar Lal Nehru Bhartiya Chikitsa Evam Homoeopathy Anusandhan Bhawan, 61-65, Institutional Area, Opp. D Block, Janakpuri

South West
DELHI
110058
India 
Phone  01128525715  
Fax    
Email  unanimedicine@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Naheed Parveen 
Designation  Assistant Director 
Affiliation  Central Council for Research in Unani Medicine (CCRUM) 
Address  Jawahar Lal Nehru Bhartiya Chikitsa Evam Homoeopathy Anusandhan Bhawan, 61-65, Institutional Area, Opp. D Block, Janakpuri

South West
DELHI
110058
India 
Phone  9213511298  
Fax    
Email  ccrum507@rediffmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Pradeep Kumar 
Designation  Research Officer (Pathology) S III 
Affiliation  Central Council for Research in Unani Medicine (CCRUM) 
Address  Jawahar Lal Nehru Bhartiya Chikitsa Evam Homoeopathy Anusandhan Bhawan, 61-65, Institutional Area, Opp. D Block, Janakpuri

South West
DELHI
110058
India 
Phone  8800263300  
Fax    
Email  drpradeepkumar2001@yahoo.com  
 
Source of Monetary or Material Support  
Infrastructural support : 1 Central Research Institute of Unani Medicine (CRIUM), Hyderabad 2. Regional Research Institute of Unani Medicine (RRIUM), Bhadrak 3. Regional Research Institute of Unani Medicine (RRIUM), Srinagar 4. Regional Research Institute of Unani Medicine (RRIUM), Aligarh Monetary Support : Central Council for Research in Unani Medicine (CCRUM), New Delhi 
 
Primary Sponsor  
Name  Central Council for Research in Unani Medicine CCRUM 
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   
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 4  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Ahmed Minhajuddin  Central Research Institute of Unani Medicine (CRIUM)  A G Colony Road, Erragadda Research OPD Room (Du‘f al-Mi‘da)
Hyderabad
TELANGANA 		 9177376011

ahmedminhajuddin@yahoo.com 
Dr Shagufta Rehman  Regional Research Institute of Unani Medicine  Post Box 70, Near Head Post Office Research OPD Room (Du‘f al-Mi‘da)
Aligarh
UTTAR PRADESH 		 9456667107

drrehmanshagufta@gmail.com 
Dr Athar Parvez  Regional Research Institute of Unani Medicine (RRIUM)  Naseem Bagh Campus, University of Kashmir Research OPD Room (Du‘f al-Mi‘da)
Srinagar
JAMMU & KASHMIR 		 9952961233

atharparvez@gmail.com 
Dr Mohd Naseem  Regional Research Institute of Unani Medicine (RRIUM)  Chandbali by pass road, near rural police station Research OPD Room (Du‘f al-Mi‘da)
Bhadrak
ORISSA 		 8327703039

rriumbdk_unani@yahoo.co.in 
 
Details of Ethics Committee  
No of Ethics Committees= 4  
Name of Committee  Approval Status 
Central Research Institute of Unani Medicine, Hyderabad  Submittted/Under Review 
Regional Research Institute of Unani Medicine, Aligarh  Approved 
Regional Research Institute of Unani Medicine, Bhadrak  Submittted/Under Review 
Regional Research Institute of Unani Medicine, Srinagar  Submittted/Under Review 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K30||Functional dyspepsia,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Majoone-Sangdana Murgh  5-10g Orally twice daily with water after meals for 6 weeks 
Comparator Agent  nil  nil 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  · Patients of either sex in the age group of 18-60
· Patients meeting the Rome III diagnostic criteria for PDS 
 
ExclusionCriteria 
Details  · Presence of GI ulcer, erosive gastritis, atrophic gastritis, severe dysplasia of gastric mucosa
or suspicious malignant lesion.
· Having overlap syndrome combined with gastro esophageal reflux disease or irritable
bowel syndrome
· Having alarm symptoms (weight loss, black or tar stool, dysphasia, etc.)
· Having any systemic disease (diseases of heart, lung, liver or kidney) or mental illness
· History of surgery related with the gastrointestinal tract more than six months ago
· Taking drugs which may affect the gastro intestinal tract, such as non-steroidal antiinflammatory
drugs and aspirin
· Known Allergy to the experimental medications
· Pregnant and breastfeeding
· Refusing to sign the informed consent 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Improvement in signs and symptoms of Du‘f al-Mi‘da (Functional Dyspepsia)  6 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
Investigations will be done at baseline and end of treatment  6 weeks 
 
Target Sample Size   Total Sample Size="240"
Sample Size from India="240" 
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 3 
Date of First Enrollment (India)   28/02/2019 
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="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   Not yet 
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   Du‘f al-Mi‘da (Functional Dyspepsia). After screening, Patients will be enrolled if they satisfy inclusion and exclusion criteria.  The patients will be assessed clinically at every two weeks. This includes subjective assessment of general well being and physical examination . The total duration of treatment will be six weeks. Laboratory parameters for safety assessment will be conducted at baseline and on completion of the protocol therapy.

Composition of Majoon-e-Sangdana Murgh

S. No.

Ingredients

Botanical / Scientific Name

Quantity

1.

Gul-e-Surkh   

Rosa damascena Mill.

100 g

2.

Post-e-Sangdana Murgh

Gizzard of the Cock/ Hen

90 g

3.

Tabasheer

Bambusa arundinacea

90 g

4.

Behman Safaid

 Centaurea behen Linn.

70 g

5.

Behman Surkh

Salvia haematodes Linn.

70 g

6.

Sandal Surkh

Pterocarpus santalinus Linn.

70 g

7.

Sandal Safaid

Santalum album Linn.

70 g

8.

Saatar Farsi

Zataria multiflora Boiss.

70g

9.

Kishneez Khushk Biryan

Coriandrum sativum Linn.

70 g

10.

Habb-ul-Aas

Myrtus communis Linn.

70 g

11.

Pudina Khushk

Mentha arvensis Linn.

45 g

12.

Post-e-Berun-e-Pista

Pistacia vera Linn.

45 g

13.

Post-e-Turanj  

Citrus medica Linn.

45 g

14.

Post-e-Halela Zard

Terminalia chebula Retz.

45 g

15.

Qand Safaid

Sugar

3 kg

 
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