DOI: 10.4103/jras.jras_292_23 ISSN: 2456-5601
Clinical evaluation of Jatiphaladya Churna and Chitrakadi Gutika in the management of Grahani (Irritable Bowel Syndrome): A prospective, multicentric, open-label study
Purnendu Panda, Banamali Das, Meda Mrutyumjaya Rao, Remya Elavana, Jeuti Rani Das, Milind Suryawanshi, Prem Bharati, Renu Singh, B. S. Sharma, Shruti Khanduri, Rakesh Kumar Rana, Arunabh Tripathi, Bhogavalli Chandra Shekhar Rao, Kartar Singh Dhiman Abstract
BACKGROUND:
Grahani
is a chronic gastrointestinal disorder characterized by persistent diarrhea and altered digestive function, often associated with the intake of incompatible or improperly digested food. In Ayurveda, the condition is fundamentally linked to
Mandagni
(impaired metabolic and digestive function), which is considered a key pathogenic factor contributing to the development of several gastrointestinal and systemic disorders.
Grahani
is among the commonly encountered clinical conditions described in Ayurvedic practice. This study aims to evaluate the therapeutic efficacy and safety of
Jatiphaladya Churna
and
Chitrakadi Gutika
, two classical Ayurvedic formulations, in the management of
Grahani
.
MATERIALS AND METHODS:
This prospective, open-label, single-arm, multicenter clinical study was conducted at the outpatient departments of the Central Ayurveda Research Institute, Bhubaneswar, Odisha, and the Regional Ayurveda Research Institute, Guwahati, Assam. A total of 100 participants aged 18–65 years diagnosed with
Grahan
i based on classical Ayurvedic parameters were enrolled after obtaining written informed consent. Participants received
Jatiphaladya Churna
(2 g) and
Chitrakadi Gutika
(500 mg) orally twice daily after meals with lukewarm water for 84 days, followed by a 14-day follow-up period. Clinical assessments, including Ayurvedic parameters and Irritable Bowel Syndrome Quality of Life (IBS-QOL) scores, were recorded at baseline and predefined follow-up visits. Therapeutic response was assessed by comparing post-treatment outcomes with baseline values using a paired
t
-test.
RESULTS:
Of the 100 enrolled participants, 93 completed the study and were included in the final analysis. Administration of
study interventions
for 84 days resulted in marked improvement in the clinical features of
Grahani
. Abdominal pain, reported in 52.7% of participants at baseline, and painful defecation, reported in 13.9%, showed complete resolution following treatment. Abdominal distension reduced from 88% at baseline to complete relief among affected participants, whereas loose stools improved from 44.1% at baseline to complete resolution. Urgency to defecate after meals decreased from 93.5% to 28%, mixed stool patterns decreased from 54.8% to 4.3%, and the sensation of incomplete evacuation decreased from 96.8% to 11.8%. Passage of stools containing undigested food particles reduced from 95.7% to 2.2%, mucous in stools from 81.7% to 4.3%, foul-smelling stools from 83.9% to 2.2%, and bitter or pungent eructation from 87.1% to 19.4%. The IBS-QOL score demonstrated a statistically significant improvement from baseline, with a mean improvement of 11.2 points (
P <
0.05). Laboratory investigations, including hepatic and renal function parameters, remained within normal reference ranges throughout the study period. No adverse drug reactions or serious adverse events were reported during the trial, indicating the safety profile of the interventions.
CONCLUSION:
The combined administration of
Jatiphaladya Churna
(2 g) and
Chitrakadi Gutika
(500 mg) twice daily for 84 days demonstrated statistically significant improvement in IBS-QOL scores. The interventions were well tolerated, with no reported adverse drug reactions and no clinically significant changes observed in hepatic or renal parameters during the study period. The findings suggest that these Ayurvedic formulations may be safe and beneficial in the management of
Grahani
and related functional gastrointestinal disorders. Further well-designed controlled studies are warranted to establish their comparative efficacy and long-term therapeutic utility.
TRIAL REGISTRATION:
CTRI/2019/08/020607 dated August 7, 2019.