Brief Summary
Modification(s)
|
SUMMARY
Ayurveda, the ancient science of life, perceives
health as a dynamic balance influenced by Kala (time) and natural
rhythms. Among the Dashavidha Parikshya Bhava, Kala holds a
central role, as expressed in “Kalo Bhaishajya Yogakrit,” signifying
that time enhances the therapeutic potential of medicine. Ayurveda highlights
both Aushadha Sevana Kala (timing of drug administration) and Anupana
(vehicle) as key determinants of treatment efficacy—concepts that parallel
modern chrono pharmacology and bioenhancers.
Jatharagnimandya, one of the most common gastrointestinal disorders in Ayurveda, results
from improper diet, inactivity, and stress, and closely resembles Functional
Dyspepsia (FD) in modern medicine, marked by epigastric pain, fullness, and
bloating. FD affects 10–40% globally and 5–30% of adults in India, indicating a
rising digestive health burden.
Hingwashtaka Churna, a classical formulation from Bhavaprakasha Madhyama Khanda,
comprises eight Deepana-Pachana ingredients—Shunthi, Maricha,
Pippali, Ajamoda, Saindhava, Shveta Jiraka, Krishna Jiraka, and Hingu.
Traditionally, it is taken with ghee before meals (Prathama Kavala Bhukta
Kala), while current practitioner often prescribes it with buttermilk after
meals (Adhobhakta Kala). Despite its established digestive actions,
there is limited clinical evidence comparing its efficacy with different
timings and vehicles. Hence, the present study aims to scientifically evaluate
the influence of Aushadha Sevana Kala and Anupana on the
therapeutic efficacy of Hingwashtaka Churna in Jatharagnimandya
(Functional Dyspepsia) through a randomized controlled clinical trial. In
this perspective, the present study was taken up with the following aims and
objective-
1.
To assess the impact of
Aushadha Sevana Kala (time of drug administration) and Anupana (vehicle) on the
therapeutic effect of Hingwashtaka Churna in patients with Jatharagnimandya
(functional dyspepsia).
2.
To evaluate the quality,
purity and strength of Hingwashtaka Churna.
To fulfill these objectives, review was made regarding
the formulation Hingwashtaka churna and Jatharagnimandya
(Functional dyspepsia) disease profile from classical and relevant modern
literature.
ingwashtaka Churna, referenced in Bhavaprakasha Madhyama Khanda (Jatharagni Vikara
Adhikara, Verse 44), is a classical digestive formulation containing eight
ingredients—Shunthi, Pippali, Maricha, Ajamoda, Saindhava Lavana, Shweta
Jeeraka, Krishna Jeeraka, and Hingu—known for their Deepana–Pachana,
Agnivardhaka, and Vata–Kapha Shamaka actions. Traditionally taken
with Sarpi (ghee) before meals, it is indicated in Agnimandya,
Ajeerna, Grahani, and Gulma. Modern studies substantiate its
digestive stimulant and gut motility–enhancing effects.
Jatharagnimandya, though not separately named in Brihatrayi, is described as
impaired digestion due to Dosha imbalance and Ama formation,
closely correlating with Functional Dyspepsia (FD), which presents with
postprandial fullness, early satiety, and epigastric discomfort. As per Rome IV
criteria, FD includes Postprandial Distress Syndrome and Epigastric
Pain Syndrome. Both Ayurveda and modern medicine acknowledge digestive
disturbance as the root of disease, reinforcing the dictum “Rogah Sarve’pi
Mandagnau.” Hence, Hingwashtaka Churna stands as an ideal
formulation to assess the influence of Aushadha Sevana Kala (time of
administration) and Anupana (vehicle) in managing Jatharagnimandya
(Functional Dyspepsia).
PHARMACOGNOSTIC
STUDY
The
pharmacognostical study of Hingwashtaka Churna was carried out to ensure
its authenticity, purity, and quality through organoleptic and microscopic
evaluations. The formulation showed a muddy brown colour, pungent aromatic
odor, and a pungent–saline taste with fine texture, consistent with its
ingredients. Microscopic analysis revealed characteristic features of each
component: Shunthi—starch grains and oleoresin; Pippali—bottle-neck
stone cells and oil globules; Maricha—lignified stone cells; Ajamoda—oil
globules and calcium crystals; Jeeraka—lignified fibers and mesocarp
cells; and Krishna Jeeraka—fibers and glandular trichomes. These
diagnostic features confirmed the genuine identity of the raw materials and
established the pharmacognostical standards of Hingwashtaka Churna.
PHARMACEUTICAL
STUDY
The physicochemical analysis of Hingwashtaka Churna
showed a loss on drying of 6.15% w/w, indicating low moisture and good
stability. Total ash (16.36% w/w) and acid-insoluble ash (3.24%) were within
permissible limits, confirming purity. The higher water-soluble extractive
value (30.30% w/w) compared to methanol-soluble (24.08% w/w) suggests
predominance of water-soluble active constituents. The formulation’s mildly
acidic pH (5) supports its digestive suitability. Preliminary phytochemical
screening revealed alkaloids, flavonoids, tannins, saponins, glycosides,
phenolics, steroids, carbohydrates, proteins, and fixed oils, indicating
diverse bioactive compounds. HPTLC analysis using piperine as a marker showed a
matching Rf value of 0.59 in both sample and standard, confirming the presence
of piperine from Pippali and Maricha, thereby validating the
formulation’s authenticity and its Deepana–Pachana (digestive stimulant)
potential.
CLINICAL
STUDY
The present clinical study was designed as a
randomized, open-label, parallel-arm controlled trial to evaluate the effect of
Aushadha Sevana Kala (time of drug administration) and Anupana
(vehicle) on the therapeutic efficacy of Hingwashtaka Churna in the
management of Jatharagnimandya (Functional Dyspepsia). The study was
conducted at the OPD of I.T.R.A. Hospital, Jamnagar, after obtaining
Institutional Ethics Committee approval (PGT/7/-A/Ethics/2023-24/2958) and CTRI
registration (CTRI/2024/08/072017). Written informed consent was obtained from
all participants before enrollment.
A total of 60 clinically diagnosed patients of Jatharagnimandya
fulfilling the diagnostic criteria (Ayurvedic and Rome IV for Functional
Dyspepsia) were selected irrespective of gender, caste, or occupation and
randomly allocated into two groups of 30 each using a computer-generated
randomization chart.
HCGP received Hingwashtaka Churna 3 g twice
daily, administered with ghee (5–10 ml) at Prathama Kavala Bhukta Kala
(with the first morsel of food), while HCTA received the same dose with
buttermilk (100 ml) at Adhobhakta Kala (after meals). The treatment
duration was 21 days, followed by a 7-day follow-up period. Patients of both
groups were advised to avoid Aharaja and Viharaja Nidanas
(causative dietary and lifestyle factors) of Jatharagnimandya.
Baseline hematological (CBC) and biochemical
investigations (LFT, RFT, RBS) were conducted before treatment to ensure
patient safety. The primary outcome measure was the change in Dyspepsia Symptom
Severity Index (DSSI) recorded on the 0th, 7th, 14th, and 21st days. The
secondary outcome was the evaluation of Jatharagnibala through
assessment of Abhyavaharana Shakti (capacity to ingest food) and Jarana
Shakti (capacity to digest food) at the same intervals.
Data
were compiled in Microsoft Excel and analyzed using paired t-test and
Wilcoxon test for within-group comparison, unpaired t-test and
Mann–Whitney U test for between-group comparison, and RM-ANOVA for assessing
time-dependent changes. RM-ANOVA evaluated both within-group (time effect) and
between-group (group effect) variations to determine therapeutic significance.
The results established the comparative efficacy of Hingwashtaka Churna
administered with different Sevana Kala and Anupana,
scientifically validating classical Ayurvedic principles of drug
administration.
Observation
and results
Out
of 64 screened patients, 2 were excluded (one with uncontrolled diabetes and
one with hypertension >190 mmHg). The remaining 62 were randomized equally
into HCGP (n=31) and HCTA (n=31). One participant from each group dropped out,
leaving 30 patients per group (N=60) for final analysis.
Demographic
Data
Baseline
comparisons showed no significant differences in demographic or clinical
parameters (p > 0.05), confirming group comparability, except for addiction
(p = 0.002). The mean age was 38.81 ± 10.70 years in HCGP and 35.52 ± 11.28
years in HCTA; baseline DSSI scores were 12.42 ± 4.01 and 12.94 ± 4.94, and Agnibala
scores 5.97 ± 1.14 and 5.84 ± 1.26, respectively (p > 0.05). Thus, both
groups were statistically homogeneous at baseline, ensuring that observed
effects were due to the interventions.
Apart
from these demographics data other health variants were as followed - Most
participants were Hindu (88%), married (60%), and from above poverty line (84%)
families, with 98% being literate. Occupationally, students (34%) and
housewives (31%) predominated. Most participants performed moderate work (81%)
and followed a vegetarian diet (72%), with irregular dietary habits (Vishamasana,
56%) being the most common. Madhura Rasa dominance (73%) and Madhyama
Kostha (80%) were frequently observed. Emotionally, 70% were stable, though
anxiety (13%) and depression (10%) were noted. Madhyama Satva (77%), and
Madhyama Satmya (93%) indicate moderate physical and mental
constitution. Overall, FD was more prevalent among young, moderately active
individuals with irregular diet, sedentary habits, and Vata–Kapha
dominance.
Effect
of Hingwashtaka Churna with Ghrita at Prathama Kavala Bhukta
Administration
of Hingwashtaka Churna with Ghrita at Prathama Kavala Bhukta
Kala produced highly significant improvement in Jatharagnimandya
(Functional Dyspepsia). The mean DSSI score reduced from 12.42 ± 4.01 to 0.57 ±
0.89 (p < 0.001), showing marked relief in dyspeptic symptoms. Agnibala
parameters—Abhyavaharana Shakti and Jarana Shakti—also improved
significantly (p < 0.001). Major symptoms like Udaragaurava and Adhmana
showed highly significant relief, while Atopa, Shirogaurava, Gatrasada,
and Ashyashosha improved markedly. Praseka and Chhardi
showed no significant change. Overall, the formulation exhibited strong Deepana–Pachana
and actions, enhancing Agnibala and alleviating dyspeptic symptoms.
Effect
of Hingwashtaka Churna with Takra at Adhobhakta Kala
Administration
of Hingwashtaka Churna with Takra at Adhobhakta Kala
produced highly significant improvement in Jatharagnimandya (Functional
Dyspepsia). The mean DSSI score reduced from 12.94 ± 4.94 to 0.53 ± 0.68 (p
< 0.001), with significant enhancement in Agnibala parameters—Abhyavaharana
Shakti and Jarana Shakti (p < 0.001). Cardinal symptoms like Udaragaurava
and Adhmana, and associated symptoms such as Atopa, Shirogaurava,
and Gatrasada showed marked relief (p < 0.001), while Praseka
and Chhardi improved mildly (p = 0.031). Overall, the formulation
exhibited strong Deepana–Pachana and Vata–Kapha Shamana effects,
significantly enhancing digestion and alleviating dyspeptic symptoms.
Comparison of both arms
Comparison
between the two treatment groups showed that Hingwashtaka Churna
administered with Ghrita at Prathama Kavala Bhukta Kala and with Takra
at Adhobhakta Kala produced comparable therapeutic outcomes in Jatharagnimandya
(Functional Dyspepsia). The mean change in DSSI and Agnibala parameters
showed no significant difference between groups (p > 0.05), indicating equal
efficacy. Among cardinal symptoms, only Udaragaurava showed a
significant difference (p = 0.028), being slightly better relieved in the group
HCTA. For associated symptoms, Praseka and Chhardi improved more
in the group HCTA, while Ashyashosha responded better in HCGP. Overall,
both regimens were equally effective in improving primary and secondary
outcomes, with each showing marginally superior relief in specific symptoms.
Repeated
Measures ANOVA showed highly significant within-group improvement in both DSSI
and Agnibala scores across the treatment period (p < 0.001),
indicating marked and progressive relief in dyspeptic symptoms and enhancement
of digestive strength with both regimens. Between-HCGPnalysis revealed no
significant difference in DSSI (p = 0.409) or Agnibala (p = 0.783), and
no significant Time × Group interaction, confirming that both administration
schedules—Hingwashtaka Churna with Ghrita before meals and with Takra
after meals—produced equally effective and parallel improvements over time.
The
efficacy of Hingwashtaka Churna remained consistent across both Aushadha
Sevana Kala and Anupana, influenced by patient and disease factors. Vata–Kapha
Prakriti predominance matched the formulation’s Vata–Kapha Shamaka
properties, while Ushna, Laghu, and Tikshna attributes balanced Doshas
and enhanced Agni. Ghrita (Snigdha, Mridu, Madhura) pacified Vata
and aided absorption, whereas Takra (Laghu, Ruksha, Ushna) reduced Kapha
and promoted Amapachana. Overall, both regimens maintained potent and
balanced digestive efficacy.
|