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CTRI Number  CTRI/2020/02/023637 [Registered on: 28/02/2020] Trial Registered Prospectively
Last Modified On: 17/02/2020
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Unani 
Study Design  Single Arm Study 
Public Title of Study   Treatment of Indigestion by Unani medicine Jawarish Pudina Wilayati 
Scientific Title of Study   Clinical Validation of Unani Pharmacopoeial Formulation Jawarish Pudina Wilayati in Su’ al-Hadm (Dyspepsia) 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
SH/D/JPW/CLNVAL/CCRUM/18-19, 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, Janakpur

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, Janakpur

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-IV 
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, Janakpur

South West
DELHI
110058
India 
Phone  8800263300  
Fax    
Email  drpradeepkumar2001@yahoo.com  
 
Source of Monetary or Material Support  
Infrastructural support : 1 Regional Research Institute of Unani Medicine (RRIUM), New Delhi 2. Clinical Research Unit (CRU), Meerut 3. Central Research Institute of Unani Medicine (CRIUM), Lucknow Monetary Support : Central Council for Research in Unani Medicine (CCRUM), New Delhi 
 
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   
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 3  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Ziaul Haq Siddiqui  Central Research Institute of Unani Medicine (CRIUM)  Research OPD Room, Dyspepsia Basaha, Kursi Road
Lucknow
UTTAR PRADESH 		 9450655974

crium_lko@yahoo.co.in 
Dr Mohd Tariq Khan  Clinical Research Unit (CRU), Meerut  Research OPD Room Dyspepsia Cantonment General Hospital Begum Bridge (Soti Ganj)
Meerut
UTTAR PRADESH 		 9012843253

doctormtk@gmail.com 
Dr Rahat Raza  Regional Research Institute of Unani Medicine (RRIUM)  Research OPD Room, Dspesia D-11, Abul Fazal Enclave, Jamia Nagar
New Delhi
DELHI 		 9911315309

razarahat@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 3  
Name of Committee  Approval Status 
Central Research Institute of Unani Medicine (CRIUM), Lucknow  Approved 
Clinical Research Unit (CRU), Meerut  Approved 
Regional Research Institute of Unani Medicine (RRIUM), New Delhi  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  Jawarish Pudina Wilayati  5 gm twice daily orally to be taken with plain water after meals for six weeks 
Comparator Agent  Nil  Nil 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1. Patients of either sex in the age group of 18-60 years
2. Patients meeting the following Rome III diagnostic criteria for post prandial distress
syndrome :
Symptom onset greater than 6 months prior to the diagnosis, with the following criteria
fulfilled for the past 3 months:
3. No structural disease by upper endoscopy to explain the symptoms
4. At least one of the following symptoms:
a. Bothersome postprandial fullness
b. Early satiation
c. Epigastric pain
d. Epigastric burning
At least one of the following:
5. Bothersome postprandial fullness after ordinary sized meals occurring at least several
times a week
6. Early satiation that prevents finishing a regular meal at least several times a week 
 
ExclusionCriteria 
Details  1. Patients showing alarm symptoms (weight loss, anaemia, haematemesis, melaena,
dysphagia, palpable abdominal mass)
2. Having any systemic disease requiring long term treatment
3. History of surgery related with the gastrointestinal tract more than six months
4. Pregnancy and lactation 
 
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 Su’ al-Hadm (Dyspepsia)  Six Weeks 
 
Secondary Outcome  
Outcome  TimePoints 
Haematological and biochemical assessment for safety assessment  Investigations will be done at baseline and end of treatment 
 
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 3 
Date of First Enrollment (India)   28/02/2020 
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 Su’ al-Hadm (Dyspepsia). After screening, Patients will be enrolled if they satisfy inclusion and exclusion criteria. The patients will be treated with Unani pharmacopoeial formulation Jawarish Pudina Wilayati 5 gm twice daily with water for six weeks.  The patients will be assessed every second week. This includes subjective assessment of general well being and physical examination . The total duration of treatment will be two years. Laboratory parameters for safety assessment will be conducted at baseline and on completion of the protocol therapy.

Composition of Jawarish Pudina Wilayati

S. No.

Ingredients

Botanical / Scientific Name

Quantity

1.

Berg Sudab

Ruta graveolens Linn.

225 gm

2.

Boora Armani

Aluminium Silicate

56 gm

3.

Zanjabeel

Zingiber officinale Rosc.

230 gm

4.

Zeera Safaid

Cuminum cyminum

185 gm

5.

Zeera Siyah

Carum carvi Linn.

375 gm

6.

Filfil Siyah

Piper nigrum Linn.

175 gm

7.

Agar Hindi

Aquilaria agallocha fungus

7 gm

8.

Ilaichi Khurd

Elettaria cardamomum Maton.

7 gm

9.

Ilaichi Kalan

Amomum subulatum Roxb.

7 gm

10.

Pudina Khushk

Mentha arvensis Linn.

7 gm

11.

Taj Qalmi

Cinnamomum tamala

7 gm

12.

Jaiphal

Myristica fragrans

7 gm

13.

Qaranful

Syzygium aromaticum Linn.

7 gm

14.

Anardana

Punica granatum Linn.

300 gm

15.

Tamar Hindi

Tamarindus indica Linn.

300 gm

16.

Maweez Munaqqa

Vitis vinifera Linn.

 300 gm

17.

Qand Safaid

Sugar

7.3 kg

18.

Sirka Desi

Vinegar

450 ml

19.

Sat Pudina

Mentha arvensis extract

10 gm

20.

Sharbat Zanjabeel

Zingiber officinale Syrup

1.1 lit.

21.

Aab Leemu

Lemon water

500 ml

 
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