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CTRI Number  CTRI/2024/08/072017 [Registered on: 07/08/2024] Trial Registered Prospectively
Last Modified On: 03/11/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Effect of Hingwashtaka-churna on Jatharagnimandhya(Functional dyspepsia) with respect to Aushadha Sevana Kala (Time of Drug administration) and Anupana (Vehicle). 
Scientific Title of Study   Therapeutic impact of Hingwashtaka-churna on Jatharagnimandhya(functional dyspepsia): the role of Aushadha Sevana Kala (time of drug administration) and Anupana (vehicle). 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Sudeepta Singh 
Designation  MD Scholar 
Affiliation  Institute of Teaching and Research in Ayurveda 
Address  Department of Dravyaguna, 3rd floor, ITRA, Jamnagar, 361008, Gujarat, India

Jamnagar
GUJARAT
361008
India 
Phone  9776043519  
Fax    
Email  sudeeptasingh72@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Kalpesh Panara 
Designation  Assistant professor 
Affiliation  Institute of Teaching and Research in Ayurveda 
Address  Department of Dravyaguna, Room. no.323, 3rd floor, ITRA, Jamnagar, 361008, Gujarat, India

Jamnagar
GUJARAT
361008
India 
Phone  9106728476  
Fax    
Email  kbpanara@itra.edu.in  
 
Details of Contact Person
Public Query
 
Name  Dr Kalpesh Panara 
Designation  Assistant professor 
Affiliation  Institute of Teaching and Research in Ayurveda 
Address  Department of Dravyaguna, Room. no.323, 3rd floor, ITRA, Jamnagar, 361008, Gujarat, India

Jamnagar
GUJARAT
361008
India 
Phone  9106728476  
Fax    
Email  kbpanara@itra.edu.in  
 
Source of Monetary or Material Support  
Institute of Teaching and Research in Ayurveda Jamnagar 361008 Gujarat 
 
Primary Sponsor  
Name  Institute of Teaching and Research in Ayurveda Jamnagar 361008 Gujarat 
Address  Opp. B- Division Police Station, Gurudwara Road, Jamnagar, Gujarat, 361008 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Sudeepta Singh  PG Hospital Institute of Teaching and Research in Ayurveda  OPD No 2 PG Hospital Institute of Teaching and Research in Ayurveda
Jamnagar
GUJARAT 
9776043519

sudeeptasingh72@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICS COMMITTEE Institute of Teaching and Research in Ayurveda  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:K929||Disease of digestive system, unspecified. Ayurveda Condition: JATHARAGNIVIKARAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Comparator ArmDrugClassical(1) Medicine Name: Hingwashtaka churna, Reference: Bhavaprakasha.ma.kha.Jatharagni vikara, Route: Oral, Dosage Form: Churna/ Powder, Dose: 3(g), Frequency: bd, Bhaishajya Kal: Grasa bhakta/Sagrasa, Duration: 21 Days, anupAna/sahapAna: Yes(details: - Ghrita), Additional Information: -Sagrasa(Prathama kavala bhukta)
2Intervention ArmDrugClassical(1) Medicine Name: Hingwashtaka churna, Reference: Bhavaprakasha.ma.kha.Jatharagni vikara, Route: Oral, Dosage Form: Churna/ Powder, Dose: 3(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 21 Days, anupAna/sahapAna: Yes(details: -Takra), Additional Information: -
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1. Patient presenting minimum 3 months of symptoms of Jatharagnimandya (functional dyspepsia)
2. Patient within the age group of 20-60 years irrespective of their gender, caste and religion.
 
 
ExclusionCriteria 
Details  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.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
- Dyspepsia Symptom Severity Index.  - on 0th,7th,14th and 21th day. 
 
Secondary Outcome  
Outcome  TimePoints 
- Health-related quality of life through Short- form Nepean Dyspepsia Index.
- Jatharagni-Bala (Abhyavaharana Shakti & Jarana Shakti) assessment.

 
on 7th, 21th, 28th day 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
Final Enrollment numbers achieved (Total)= "60"
Final Enrollment numbers achieved (India)="60" 
Phase of Trial   Phase 2/ Phase 3 
Date of First Enrollment (India)   24/08/2024 
Date of Study Completion (India) 15/09/2025 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary
Modification(s)  

                                                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.

 


 
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