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CTRI Number  CTRI/2025/02/080956 [Registered on: 20/02/2025] Trial Registered Prospectively
Last Modified On: 03/02/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Unani 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Treatment of prolonged indigestion with polyherbal unani formulation Qurs-e-Tinkar 
Scientific Title of Study   A clinical study to evaluate the Therapeutic effect of Qurs-i- Tinkar in management of Du‘f al-Hadm (Functional Dyspepsia) – A randomized double blind standard controlled trial. 
Trial Acronym  Nill 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Muhammed Ubaide 
Designation  PG Scholar 
Affiliation  Luqman Unani Medical College Hospital and Research Centre Vijayapura Karnataka 586101 
Address  Department of Moalajat OPD ground floor Luqman Unani Medical College Hospital and Research Centre VijayaPura Karnataka 586101

Bijapur
KARNATAKA
586101
India 
Phone  8095290951  
Fax    
Email  muhammedubaide@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Mohd Qudrathullah 
Designation  Khan Professor, HOD Moalajat LUMC 
Affiliation  Luqman Unani Medical College Hospital and Research Centre VijayaPura Karnataka 586101 
Address  Department of Moalajat OPD ground floor Luqman Unani Medical College Hospital and Research Centre VijayaPura Karnataka 586101

Bijapur
KARNATAKA
586101
India 
Phone  9849438319  
Fax    
Email  drmqkhan@yahoo.com  
 
Details of Contact Person
Public Query
 
Name  Dr Saba Mamdapur 
Designation  Professor, Dept. of Moalajat, LUMC 
Affiliation  Luqman Unani Medical College Hospital and Research Centre VijayaPura Karnataka 586101 
Address  Department of Moalajat OPD ground floor Luqman Unani Medical College Hospital and Research Centre VijayaPura Karnataka 586101

Bijapur
KARNATAKA
586101
India 
Phone  09611497816  
Fax    
Email  dr.sabamamdapur@gmail.com  
 
Source of Monetary or Material Support  
Luqman Unani Medical College Hospital and Research Center 12 Naubag,Vijayapura (Bijapur),Karnataka 586101 
 
Primary Sponsor  
Name  Luqman Unani Medical College Hospital and ResearchCenter 
Address  12 Naubag, Vijayapura (Bijapur),Karnataka 586101 
Type of Sponsor  Private medical college 
 
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 
Dr Muhammed Ubaide  Luqman unani medical college hospital and research centre  Department of Moalajat OPD ground floor Luqman Unani Medical College Hospital and Research Centre VijayaPura Karnataka 586101
Bijapur
KARNATAKA 
8095290951

muhammedubaide@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Communication of Decision of the Institutional Ethical Committee (IEC) for Bio Medical Research  Approved 
 
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  Qurs-i-Tinkar  Form Tablet Route of administration Oral Dosage two tablets twice daily 250mg each with 1 glass of normal water for a period of 28 days Follow up 0th 7th 14th 21st and 28th day of trial 
Comparator Agent  Rabeprazole 20mg  Form Tablet Route of administration Oral Dosage 20 mg twice daily with 1 glass of normal water Follow up 0th 7th 14th 21st and 28th day of trial 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  40.00 Year(s)
Gender  Both 
Details  1 Individuals of any gender aged between 18 and 40 years
2 Patients who meet the diagnostic criteria outlined in the "Rome IV" guidelines for Functional dyspepsia. These criteria require the presence of symptoms for at least three months within the past six months prior to diagnosis including experiencing one or more of the following
a Bothersome postprandial fullness
b Bothersome early satiation
c Bothersome epigastric pain
d Bothersome epigastric burning
3 Individual who is willing to provide voluntary consent 
 
ExclusionCriteria 
Details  1 People aged 41 years or older exhibiting symptoms including weight loss alongside dyspepsia reflux treatment-resistant dyspepsia dyspepsia with elevated platelet count nausea vomiting or low hemoglobin levels
2 Individuals of any age experiencing difficulty swallowing (dysphagia)
3 Individuals presenting with vomiting blood (hematemesis)
4 Upper abdominal mass felt on palpation
5 Any previous or family history of GI Cancer
6 Dyspepsia overlapping Irritable Bowel Syndrome (IBS) symptoms
7 Those with a known hypersensitivity to the study drug or any of its ingredients
8 Previously diagnosed cases of organic gastrointestinal diseases
9 Any previous history of abdominal surgery
10 Known case of systemic illness such as malignant hypertension diabetes mellitus cardiopulmonary diseases etc
11 Pregnant and lactating females 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
Global Overall Symptom (GOS) Scale (using 7 point Likert scale, participants are asked to grade the overall severity of 10 upper gastrointestinal symptoms)  Primary outcome will be measured at every follow up. 
 
Secondary Outcome  
Outcome  TimePoints 
Overall treatment effect (OTE)  1st, 2nd, 3rd and 4th follow up 
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
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)   25/02/2025 
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   N/A 
Individual Participant Data (IPD) Sharing Statement

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

Response - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report
    Response -  Analytic Code

  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [muhammedubaide@gmail.com].

  6. For how long will this data be available start date provided 27-02-2027 and end date provided 02-02-2029?
    Response - Beginning 3 months and ending 5 years following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - Nill
Brief Summary  
The Real Academia Española defines dyspepsia as chronic digestive difficulty, a term derived from the Greek roots "dys" (bad or difficult) and "peptos" (to digest), meaning "poor digestion" .[27] In Standard Unani medical terminology, Du‘f al-Hadm describes delayed digestion without structural abnormalities, causing discomfort and digestive issues.[13]
Functional dyspepsia is characterized by bothersome symptoms in the upper gastrointestinal tract, such as difficulty completing a meal (early satiety), feeling excessively full after eating (postprandial fullness), and experiencing discomfort like pain or burning in the upper abdomen. (1) The cause of functional dyspepsia is likely a combination of various factors, although it’s not fully understood. Risk factors include psychological issues, recent gastroenteritis, being female, smoking, using non-steroidal anti-inflammatory drugs, and having an H. pylori infection. The condition’s mechanisms involve disrupted communication between the gut and brain, leading to gut movement problems, heightened abdominal sensitivity, and changes in gut microbiota, mucosal and immune functions, and central nervous system processing. (2,3)
The prevalence of functional dyspepsia varies worldwide, ranging from 10% to 40% in Western countries like the US and 5% to 30% in Asian countries. It is more common in women than in men, and developing countries tend to have higher rates than developed ones. Overall, globally, more than three-quarters of dyspepsia cases are classified as functional dyspepsia, meaning no organic cause has been identified. (2,4)
A classic presentation of persistent early satiety and postprandial fullness is often adequate to diagnose and initiate treatment or conduct a thorough evaluation. Diagnosis is typically based on a patient’s symptoms, age, and medical history. (1,5)
The mainstay treatment for functional dyspepsia involves a course of proton pump inhibitors (PPIs) over 4 to 8 weeks to decrease stomach and duodenal acid levels. Combining PPIs with prokinetics can boost effectiveness, especially for these patients. For those unresponsive to prokinetics, fundic relaxors like Cisapride may be considered. Low-dose tricyclic antidepressants have shown effectiveness in relieving epigastric pain. Rifaximin may help address microbiome disturbances with its antibiotic and anti-inflammatory properties.
Additionally, cognitive behavioral therapy is a viable option for those with significant psychological factors. Probiotics also offer potential benefits in managing symptoms through various mechanisms. (2,6,49,52)
Extended usage of proton pump inhibitors (PPIs) comes with notable health hazards. Hypomagnesia may occur due to PPIs, lowering magnesium levels to a degree not easily rectified by supplements, leading to tetany, seizures, muscle weakness, and irregular heart rhythms. PPIs also reduce stomach acidity, fostering bacterial overgrowth, which heightens infection risks and the likelihood of bacterial aspiration. Discontinuing PPIs can sometimes trigger rebound acid secretion, resulting in even higher acid levels than before treatment. Long-term PPI use may induce vitamin B12 deficiency and hypergastrinaemia, elevating the risk of gastric carcinoid formation and gastric cancer by 82%. Moreover, studies suggest a link between PPIs and colorectal cancer, possibly due to changes in intestinal flora and gastrin’s tumor-promoting effects. Furthermore, hypergastrinaemia from prolonged PPI use may contribute to pancreatic cancer development. These risks underscore the importance of cautious PPI usage and regular monitoring for those on extended therapy. (7,8,9,10) Although dyspepsia is acknowledged as a significant health concern within the community, the conservative annual cost estimate for Functional dyspepsia in the US totaled $18.4 billion, indicating that treatment remains inadequate. Patients with functional dyspepsia experience a significant decrease in their health-related quality of life, which encompasses both physical and emotional functioning. (11,12,51)
Consequently, the quest for a safe and efficient medication has been a focal point of research. worldwide, notably within the field of Unani system of medicine. Functional dyspepsia in the Unani system is characterized by weakness of the Digestion (Du‘fal-Hadm), altered digestion (Su’ al-Hadm), and delayed digestion. (13,14)
It is caused by factors like altered stomach temperament most dominantly due to Cold (15,16,17), weak stomach function, gastroparesis (18), accumulation of morbid matter, retention of gases[18], and dietary irregularities (14). Symptoms include restlessness, nausea, vomiting, constipation, white diarrhea, burping, sour taste in the mouth, weakness, headache, stomach pain, frothy urine, heartburn, and heaviness after meals (14). This condition reflects poor digestion, leading to undigested food taste in belching, (19) and anorexia. (17)
Esteemed Unani scholars have documented safe and effective treatments for Du‘f al-Hadm (Functional Dyspepsia), incorporating both individual and compound formulations. These formulations include common ingredients such as black salt (sodium chloride), borax (sodium tetraborate decahydrate), lemon (Citrus lemon-Linn), ginger (Zingiber Officinalis), mace (Myristica fragrans), cinnamon (Cinnamomum verum), black cumin (Nigella sativa), asafoetida (Ferula asafoetida), cardamom (Elettaria cadamomum), star anise (Illicium verum), spearmint (Mentha spicata), among others (20). Additionally, various compound formulations such as Jawarish Ood Shirin, Jawarish Mastagi, Jawarish Kamuni, Jawarish Bisbasa, Murabba-i-Haleela, Murabba-i- Amla, Arq-i-Darchini, Habb- i-Hadim, Hab-i- Hiltit (17) Hab-i- Papita (21), Sufuf-i-Hadim Ulvi Khan (17) Habb-i- Tinkar (21), Qurs-i-Kokab (22), and Qurse-i-Tinkar (23) are also documented in authentic Unani literature for addressing this condition. Qurse-Tinkar is highly significant in Unani Medicine for effectively managing functional dyspepsia, commonly known as indigestion. It’s diverse actions and therapeutic effects on digestion make it invaluable in treating this condition.
Classical Unani texts provide detailed descriptions of its therapeutic benefits, such as its Hadim(digestive),Kasir-i-riyah(carminative),Musakkin(analgesic),Muhallil(resolving),Mushtahi (appetizing),Mulayyin(laxative),and Muqawwi Meda wa Jigar (tonic properties for the stomach and liver). (21, 23,24,25,26) The therapeutic effects of Qurs-i-Tinkar have not yet been analyzed scientifically. Hence, based on this information, the current research is titled “A clinical study to evaluate the Therapeutic effect of Qurs-i-Tinkar in management of Du‘f al-Hadm (Functional Dyspepsia) – A randomized double blind standard controlled trial”.
 
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