| CTRI Number |
CTRI/2025/12/099579 [Registered on: 22/12/2025] Trial Registered Prospectively |
| Last Modified On: |
10/12/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A Clinical Study To Assess The Effect Of Ayurveda Treatment Protocol In Patients With Hyperacidity (Amlapitta) |
|
Scientific Title of Study
|
Efficacy Of Ayurveda Treatment Protocol Compared To Vonoprazan In Patients With Functional Dyspepsia (Amlapitta) A Randomized Controlled Trial |
| Trial Acronym |
FD |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Zanzad Vrushali Bhagwan |
| Designation |
PG Scholar |
| Affiliation |
KAHERs Shri BMK Ayurveda Mahavidyalaya Post Graduate Studies And Research Centre Shahapur Belagavi |
| Address |
Department Of Kayachikitsa KAHERs Shri BMK Ayurveda
Mahavidyalaya Post Graduate Studies And Research Centre
Shahapur Belagavi
Belgaum
KARNATAKA
590003
India
Belgaum
KARNATAKA
590003
India |
| Phone |
9284103815 |
| Fax |
|
| Email |
vrushalizanzad009@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr R Sunil Kumar |
| Designation |
Reader |
| Affiliation |
KAHERs Shri BMK Ayurveda Mahavidyalaya Post Graduate Studies And Research Centre Shahapur Belagavi |
| Address |
Department Of Kayachikitsa KAHERs Shri BMK Ayurveda
Mahavidyalaya Post Graduate Studies And Research Centre
Shahapur Belagavi
Belgaum
KARNATAKA
590003
India
Belgaum
KARNATAKA
590003
India |
| Phone |
8309545056 |
| Fax |
|
| Email |
dr.sunil.devaki@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr R Sunil Kumar |
| Designation |
Reader |
| Affiliation |
KAHERs Shri BMK Ayurveda Mahavidyalaya Post Graduate Studies And Research Centre Shahapur Belagavi |
| Address |
Department Of Kayachikitsa KAHERs Shri BMK Ayurveda
Mahavidyalaya Post Graduate Studies And Research Centre
Shahapur Belagavi
Belgaum
KARNATAKA
590003
India
Belgaum
KARNATAKA
590003
India |
| Phone |
8309545056 |
| Fax |
|
| Email |
dr.sunil.devaki@gmail.com |
|
|
Source of Monetary or Material Support
|
| KAHERs Shri BMK Ayurveda Mahavidyalaya Post Graduate Studies And Research Centre
Shahapur Belagavi Karnataka India 590003 |
|
|
Primary Sponsor
|
| Name |
Dr Zanzad Vrushali Bhagwan |
| Address |
KAHERs Shri BMK Ayurveda Mahavidyalaya Post Graduate Studies
And Research Centre Shahapur Belagavi |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Zanzad Vrushali Bhagwan |
KLE Ayurveda Hospital And Medical Research Centre |
OPD No 6,7 Department
Of Kayachikitsa KLE
Ayurveda Hospital And
Medical Research
Centre Shahapur
Belagavi
KARNATAKA
Belgaum
KARNATAKA |
9284103815
vrushalizanzad009@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee For Research On Human Subjects KAHERS Shri B M Kankanawadi Ayurveda Mahavidyalaya And KLE Ayurveda Hospital Shahapur Belagavi |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:K30||Functional dyspepsia. Ayurveda Condition: AMLAPITTAM, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Avipattikar Churna, Reference: Bhaishajya Ratnavali Amlapittadhikar, Route: Oral, Dosage Form: Churna/ Powder, Dose: 3(g), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 28 Days, anupAna/sahapAna: Yes(details: Water), Additional Information: As per types of Amlapitta it will be given along with three different medicines- In Vataj Amlapitta with Kamdudha rasa, In Vatakaphaj Amlapitta with Shankha Vati, In Kaphaj Amlapitta with Leelavilasa rasa.(2) Medicine Name: Kamdudha rasa, Reference: Rasayoga Sagar Amlapitta Rogadhikar, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 250(mg), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 28 Days, anupAna/sahapAna: Yes(details: Water), Additional Information: In Vataj Amlapitta: Kamdudha rasa and Avipattikar Churna.(3) Medicine Name: Shankha Vati, Reference: Bhaishajya Ratnavali Agnimandya Rogadhikar, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 250(mg), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 28 Days, anupAna/sahapAna: Yes(details: Water), Additional Information: In Vatakaphaj Amlapitta: Shankha Vati and Avipattikar Churna.(4) Medicine Name: Leelavilasa rasa, Reference: Yogaratnakara Amlapitta Chikitsa, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 250(mg), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 28 Days, anupAna/sahapAna: Yes(details: Water), Additional Information: In Kaphaj Amlapitta: Leelavilasa rasa and Avipattikar Churna. | | 2 | Comparator Arm (Non Ayurveda) | | - | Tab. Vonoprazan 20mg | Tab. Vonoprazan 20mg, Once daily with Water,Before food for 28 days. |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Age between 18 and 60 Years.
2.Sex : Both sexes.
3.Patients with signs and symptoms of Functional Dyspepsia.
4.Patients with signs and symptoms of Amlapitta.
5.Patients who are willing to give written informed consent.
6.Those patients who are on existing FD treatment will be asked to undergo a 7 days wash out period. After this interval, they may be included in our study.
|
|
| ExclusionCriteria |
| Details |
1.Patients who are regularly consuming NSAIDs, low dose aspirin will be excluded.
2.Patients having History of bleeding disorders.
3.Known case of CA stomach and TB.
4.History(within 6months) or diagnosed case of H.pylori infection.
5.Patients with history of uncontrolled HTN/DM and other major systemic illness.
6.Pregnant women , lactating mother.
7.Those high risk patients who are having upper Gastrointenstinal pathology which require Upper GI Endoscopy for evaluation.
8.Patients suffering or having history of peptic ulcer, gastric or esophageal malignant disease or patient undergone gastrectomy.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| SF-LDQ Criteria (Short form leeds dyspepsia questionarre) |
Baseline,14th day,28th day,42th day,56th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Amlapitta symptom rating scale.
2.VAS scale analysis.
|
Baseline,14th day,28th day,42th day,56th day |
1.NDI (Nepean Dyspepsia Index)
2.GDSS (Glassgow Dyspepsia Severity Score)
3.AST (Aspartate Amino Transferase)
4.ALT (Alanine Amino Transferase)
5.Serum Creatinine |
Baseline, 28th day |
| HB% (Haemoglobin percentage) |
Baseline |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
06/01/2026 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
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
|
Functional Dyspepsia is common type of Functional Gastro- Intestinal Disorder having high prevalence of 20-40 % and impact on quality of life. The current management strategies in modern medicine primarily are using of proton pump inhibitors, antacids, H2 blockers and prokinetics which may offer only temporary benefit and are often associated with adverse effects or recurrence upon discontinuation. Amlapitta, as described in Ayurveda, is a prevalent gastrointestinal disorder characterized by symptoms such as Avipaka (indigestion), Tikta-Amla Udgara (sour or bitter belching), Hrit-Kantha Daha (burning sensation in chest and throat), and Gaurava (heaviness). These symptoms show a close resemblance to the modern clinical entity of Functional Dyspepsia (FD), a chronic gastrointestinal disorder defined by upper abdominal discomfort or pain without any identifiable organic cause. Inspite of Vast Clinical experience from various Ayurveda Practitioners, treatment of Amlapitta based on dosha predominance requires scientific evidence. Scientifically evaluate the efficacy and safety of selected Ayurvedic treatment(s) in the management of Functional Dyspepsia. Provide a cost-effective, side-effect-free, and sustainable treatment alternative to conventional therapies. Generate evidence-based data that could support the integration of Ayurvedic approaches in mainstream gastrointestinal care. Contribute towards the global recognition and acceptance of Ayurveda in managing psychosomatic and lifestyle-related digestive disorders. Very few RCTs comparing Ayurveda treatments in line with modern conventional drugs.Hence the Ayurveda treatment protocol which is efficacious, safe, affordable and alternative to conventional system of medicine is the needed. |