Therapeutic impact of Hingwashtaka-churna on Jatharagnimandhya(functional dyspepsia): the role of Aushadha Sevana Kala (time of drug administration) and Anupana (vehicle).
试验速览
- 阶段
- 2/3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- - Dyspepsia Symptom Severity Index.
研究概览
简要总结
SUMMARY
Therapeutic Impact of Hingwashtaka Churna on Jatharagnimandya (Functional Dyspepsia): The Role of Aushadha Sevana Kala (Time of Drug Administration) and Anupana (Vehicle).
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 20.00 Year(s) 至 60.00 Year(s)(—)
- 性别
- All
入选标准
- •Patient presenting minimum 3 months of symptoms of Jatharagnimandya (functional dyspepsia) 2.
排除标准
- •Diagnosed patients of uncontrolled Diabetes mellitus, HTN, IHD, Malignancies, STD’s, Thyroid Disorders.
- •2.Known case of complicated GI Disorders such as Peptic ulcer, Gastroesophageal reflex disease (GRD), Gastric Ulcer, Duodenal ulcer, Ulcerative Colitis, Chronic constipation, IBS, Severe abdominal pain.
- •3.Lactating Mother and Pregnant women.
- •4.Alcohol abuse or drug dependence.
- •5.Amlapita, Vidagdhajirna, Raktatisara, Raktarsha, Bhagandara (Fistula in Ano) 6.Jalodara (Ascites), Rajayakshma (Tuberculosis) and any other medical and surgical major illness.
结局指标
主要结局
- Dyspepsia Symptom Severity Index.
时间窗: - on 0th,7th,14th and 21th day.
次要结局
- - Health-related quality of life through Short- form Nepean Dyspepsia Index.(- Jatharagni-Bala (Abhyavaharana Shakti & Jarana Shakti) assessment.)
研究者
Sudeepta Singh
Institute of Teaching and Research in Ayurveda
