| CTRI Number |
CTRI/2025/12/098907 [Registered on: 11/12/2025] Trial Registered Prospectively |
| Last Modified On: |
09/12/2025 |
| 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
|
Pranada Gutika v/s Avipattikara Churna in Amlapitta. |
|
Scientific Title of Study
|
A Randomized Controlled Clinical trial to
evaluate the efficacy of Pranada Gutika and
Avipattikara Churna in the management of
Amlapitta. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Rohit kumar |
| Designation |
Pg Scholar |
| Affiliation |
Institute for Ayurved Studies and Research |
| Address |
Room no 79 PG Department of Kayachikitsa, Institute for Ayurved Studies and Research
umri road sector 8 kurukshetra
Kurukshetra
HARYANA
136118
India |
| Phone |
8708912796 |
| Fax |
|
| Email |
rohit.kaushik.92167@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Neelam kumari |
| Designation |
Professor, PG Department of Kayachikitsa |
| Affiliation |
Institute for Ayurved Studies and Research |
| Address |
Room no 79 PG Department of Kayachikitsa, Institute for Ayurved Studies and Research
umri road sector 8 kurukshetra
Kurukshetra
HARYANA
136118
India |
| Phone |
9671368058 |
| Fax |
|
| Email |
mehranilam@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Rohit kumar |
| Designation |
Pg Scholar |
| Affiliation |
Institute for Ayurved Studies and Research |
| Address |
Room no 79 PG Department of Kayachikitsa, Institute for Ayurved Studies and Research
umri road sector 8 kurukshetra
Kurukshetra
HARYANA
136118
India |
| Phone |
8708912796 |
| Fax |
|
| Email |
rohit.kaushik.92167@gmail.com |
|
|
Source of Monetary or Material Support
|
| Institute for Ayurved Studies and Research sector-8 umri road , kurukshetra
Pincode -136118 |
|
|
Primary Sponsor
|
| Name |
Institute for Ayurved Studies and Research |
| Address |
Sector-8 umri road kurukshetra
136118 |
| Type of Sponsor |
Government medical college |
|
|
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 Rohit kumar |
Institute for Ayurved studies and research |
Room no. 56 Pg department of Kayachikitsa.
136118
Kurukshetra
HARYANA |
8708912796
rohit.kaushik.92167@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Shri Krishna Ayush University |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:K318||Other specified diseases of stomach and duodenum. Ayurveda Condition: AMLAPITTAM, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Avipattikara Churna , Reference: : Bhaishajya Ratnavali 56/25-29, Route: Oral, Dosage Form: Churna/ Powder, Dose: 3(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 28 Days, anupAna/sahapAna: Yes(details: -ushanodka ), Additional Information: - | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Pranda Gutika , Reference: Bhaishjya ratanvali , Chikitsa Prakrna, Arshorogachikitsa slok no 64 to 73, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 2(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 28 Days, anupAna/sahapAna: Yes(details: -Ushanaodka ), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
1. Willing for clinical trials and ready to give written consent.
2. Age 20-50 years.
3. Patient of either sex, religion.
4. Patients with cardinal symptoms of Amlapitta viz. Avipaka, Klma, Utklesha, Tikta Amla
Udgara, Guruta, Hrit-Kantha Daha, Aruchi.
• Patient willing to take ayurveda treatment.
|
|
| ExclusionCriteria |
| Details |
1. Bahudosha Avastha that required Shodhana Chikitsa.
2. Patient already suffering with CA stomach.
3. Already diagnosed cases of peptic ulcer disease.
4. H/O hematemesis, melena and other systemic disorder that interfere with clinical trial. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The proportion of patients showing improvement in the score of assessment criteria of Amlapitta. |
28 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Improving digestion health.
2.Reducing dependency on medication.
3.Enhancing life style management.
4.Improving strength of immune system. |
28 days |
|
|
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)
|
02/03/2026 |
| 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 Yet Recruiting |
| 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
|
According to Ayurveda, the root cause of all diseases is Agnimandhya (weak digestive fire), which arises from unhealthy lifestyles and incompatible diets (viruddhahara). These habits vitiate the tridoshas, further weakening Agni and disturbing Pachaka Pitta. This leads to increased drava and amla guna of pitta, causing vidagdha pitta and resulting in Amlapitta, correlated with hyperacidity in modern medicine. Hyperacidity occurs when excessive stomach acid disrupts digestive balance. Ayurveda manages Amlapitta through dietary regulation, herbal remedies, and lifestyle modifications to restore Pitta balance. Globally, around 20% of people experience hyperacidity, with an Indian survey (2021) showing 32% prevalence among adults aged 30–44, increasing with age. |