Mustakarishta in the management of Irritable Bowel Syndrome

Phase 2/3

Not yet recruiting

• Conditions: Mixed irritable bowel syndrome,

• Registration Number: CTRI/2019/09/021371
• Lead Sponsor: CCRAS

Brief Summary

According to Ayurveda “*RogaahSarvepi**mandagnou sudaramudarani cha*†means all the diseasesare caused by *mandagn**i* ((digestive fire orvarious enzymatic process involved in digestion, absorption and metabolism atvarious level) which causes improper digestion of ingested nutrients (food)leading to formation or accumulation of *Amadosha* (intermediateproducts/or toxins) which produces its effect locally or generalized) .Grahani(middle part of amasaya and pakwasaya) is the place of Jatharagni.When the digestive power of Grahani become weaken due to the improper food habits and stressfull lifestyle, It causes Grahani roga which is also knownas Grahani in Ayurveda. In general, the digestion andabsorption of food materials can be divided into 3 major phases: Luminal,Mucosal and Post - absorptive phases. The luminal phase in which thefats, proteins, and carbohydrates are hydrolyzed and solubilized bysecreted digestive enzymes and bile can be considered to be the role of PachakaPitta which is responsible for the breakdown and synthesis of substances i.e.catabolic and anabolic activities. Mucosal phase relies on the integrity of thebrush-border membrane of intestinal epithelial cells to transport digestedproducts from the lumen into the cells is compared to *Kledaka Kapha*by  the virtue of its cooling propertywhich  counter the heating property ofPitta.  In modern medicine, the diseasecan be co-related with malabsorption syndrome and also Irritable BowelSyndrome. There are enormous formulations mentioned in Ayurvedic classics forthe augmentation and restoration of Agnibala in general and Grahaniin particular. The Mustakarishta is areputed formulation, mentioned in the Bhaishajya Ratnavali, aclassical  text ofAyurveda forthe treatment of Ajirna,Agnimandya,Grahani, Visuchika etc.

As Grahani roga is caused due toagnimandya, the main line of treatment is to correct the agnidusti byadministering drugs which are deepana and pachana in nature. The trial drug Mustakarishta is a classical medicine mentioned in Bhaishajya Ratnavali as well as AFI- Part-I, 1:26(pg. 17) and API Part – II, Vol.II (1stedition, pg. 45). The Ingredients contain in this trial medicine are  having properties like *deepan, pachana*and *sthambhaka* and can able to correct the agnimandya condition anddisorders of *Purishavaha s**rotas*.

So  the aim and object of the present study isplanned to evaluate therapeutic efficacy of Mustakarishtain thepatients of Grahani along with safety measures by observing adverseevents (AE) if any or Adverse drug reaction (ADR). The efficacy of the trialdrug would be assessed by observing the improvement in Subjective parameters(Clinical Symptoms). Improvement in WHOQOL score and lab. parameters.

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2019-09-20
• Study Start: 2019-09-26

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

Known cases of Grahani (diagnostic criteria as per classical Ayurvedic parameters) Patients willing to give written informed consent to participate in the study.

Exclusion Criteria

• 1.Patients with history of Inflammatory Bowel Disease (IBD), Koch’s abdomen, Gluten intolerance.
• 2.Patients with history of chronic Amoebiasis.
• 3.Known cases of Diabetes Mellitus.
• 4.Patients with poorly controlled Hypertension ( >160/100 mmHg) 5.Patients who have history of Atrial Fibrillation, Acute Coronary Syndrome, Myocardial Infarction, Stroke or Severe Arrhythmia in the last 6 months 6.Symptomatic patients with clinical evidence of Heart failure 7.Known cases of malignancy 8.Patients with concurrent serious hepatic disorders (defined as Aspartate Amino Transferase (AST) and / or Alanine Amino Transferase (ALT) > 2 times upper normal limit) or Renal Disorders (defined as S.
• Creatinine >1.2mg/dL), Severe Pulmonary Dysfunction (uncontrolled Bronchial Asthma and / or Chronic Obstructive Pulmonary Disease (COPD).
• 9.Women who are planning for conception / pregnant or lactating.
• 10.H/o hypersensitivity to any of the trial drugs or their ingredients 11.Patients who have completed participation in any other clinical trial during the past three months 12.Any other condition which the Investigator thinks may jeopardize the study.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To assess the clinical efficacy of Mustakarishta by the assessment of Changes in Ayurvedic Parameters of Grahani.	Bseline,on 14th day, 28th day, 42th day, 56th day, 70th day,84th day,98th day

Secondary Outcome Measures

Name	Time	Method
To assess the clinical efficacy of Mustakarishta by the assessment of Changes in IBS-QOL score.	Baseline,on 14th day, 28th day, 42th day, 56th day, 70th day,84th and 98th day

Trial Locations

Locations (2)

CARIHD,Hospital; 🇮🇳 Khordha, ORISSA, India

RARIGID Hospital;Guwahati; 🇮🇳 Kamrup, ASSAM, India

CARIHD,Hospital

🇮🇳Khordha, ORISSA, India

DrGurucharan Bhuyan

Principal investigator

9958355177

drbhuyangc@gmail.com