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.

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”.