Jatiphaladi Churna and Chitrakadi Gutika in the treatment of Grahani (Irritable bowel Syndrome)

Phase 2/3

Not yet recruiting

• Conditions: Mixed irritable bowel syndrome,

• Registration Number: CTRI/2019/08/020607
• Lead Sponsor: CCRASNew Delhi

Brief Summary

According toAyurveda “Rogaah Sarvepimandagou†means all the diseases are caused by mandagin((digestive fire or various enzymatic process involved in digestion,absorption and metabolism at various level) which causes improper digestion ofingested nutrients (food) leading to formation or accumulation of Amadosha(intermediate products/or toxins) which produces its effect locally orgeneralized) .Grahani (middle part of amasaya and pakwasaya) is the place ofJatharagin. When the digestive power of grahani became less due to the improperfood habits and stressfull life style. It causes Grahani roga which is known asGrahani in Ayurveda. In general, the digestion and absorption of food materialscan be divided into 3 major phases: Luminal, Mucosal and Post - absorptivephases. The luminal phase in which di fats, proteins, and carbohydrates arehydrolyzed and solubilised by secreted digestive enzymes and bile can beconsidered to be the role of Pachaka Pitta which is responsible for thebreakdown and synthesis of substances i.e. catabolic and anabolic activities.Mucosal phase relies on the integrity of the brush-border membrane ofintestinal epithelial cells to transport digested products from the lumen intothe cells is compared to Kledaka Kapha by the virtue of its cooling property which counter the heating property of Pitta.  In modern medicine, the disease can be co-relatedwith malabsorption syndrome and also Irritable Bowel Syndrome. There areenormous formulations mentioned in Ayurvedic classics for the augmentation andrestoration of Agnibala in general and Grahani in particular.JatiphaladyaChurna & Chitrakadi gutika are reputed formula, though mentioned in theSarangadhara Samhita and Charaka Samhita respectively in Ayrveda classics, for thetreatment of Grahani, Atisara, Agnimandya etc.

Asgrahani roga is caused due to agnimandya, the main line of treatment is tocorrect the agnidusti by administering drugs which are deepana and pachana inaction. The trial durgs like Jatiphaladi Churna and Chitrakadi Gutika are  classical medicines formulated by AcharyCharak and Acharya Sarangadhara.Which are referred to AFI,Part-I, 7:12. andAFI,Part-I, 12:11. The Ingredients which these trial medicines are  contains, having properties like deepan,pachana and sthambhaka and can able to correct the agnimandya condition anddisordered of purishavaha stoats.

So  the aim and object of the present study isplanned to evaluate therapeutic efficacy of Jatiphaladi Churna and ChitrakadiGutika in the patients of Grahani along with safety measures by observingadverse events (AE) if any or Adverse drug reaction (ADR). The efficacy ofthese drugs would be assessed by observing the improvement in Subjectiveparameters (Clinical Symptoms). Improvement in WHOQOL score and lab parameters.

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2019-06-08
• Study Start: 2019-08-21

Recruitment & Eligibility

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

Inclusion Criteria

1.Patients of either sex aged 18-65 years 2.Known cases of Grahani (diagnostic criteria as per classical Ayurvedic Parameters) with following symptoms 3.Patients willing to give written informed consent and able to participate for 3 months.

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 Jatiphaladya Churna & Chitrakadi Gutika by the assessment of Changes in Ayurvedic Parameters of Grahani	Base line , At the end of 14th day, 28th day, 42nd day, 56th day, and 70th day, 84th day and 98th day.

Secondary Outcome Measures

Name	Time	Method
To assess the clinical efficacy of Jatiphaladya Churna & Chitrakadi Gutika by the assessment of Changes in IBS-QOL score	Base line , At the end of 14th day, 28th day, 42nd day, 56th day, and 70th day, 84th day and 98th day.

Trial Locations

Locations (2)

CARIHD HOSPITAL Bhubaneswar; 🇮🇳 Khordha, ORISSA, India

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

CARIHD HOSPITAL Bhubaneswar

🇮🇳Khordha, ORISSA, India

Dr Purnendu Panda

Principal investigator

9777852889

pandapurnendu02@yahoo.com