| CTRI Number |
CTRI/2025/08/092215 [Registered on: 01/08/2025] Trial Registered Prospectively |
| Last Modified On: |
31/07/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug Ayurveda Other (Specify) [randomized controlled phase 2] |
| Study Design |
Other |
|
Public Title of Study
|
A clinical study to see effect of Amlapittahar syrup in hyperacidity. |
|
Scientific Title of Study
|
An open labelled prospective randomized controlled phase 2 clinical study to evaluate efficacy of Amlapittahar syrup for Urdhwag Amlapitta [Hyperacidity] |
| 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 Sheetal Chavan |
| Designation |
Associate Professor, Dept of of Rognidan evum Vikruti Vigyan |
| Affiliation |
|
| Address |
OPD no 7 Rognidan vibhag
Nashik MAHARASHTRA 422003 India |
| Phone |
9272642873 |
| Fax |
|
| Email |
dr.sheetalyadav59@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Sheetal Chavan |
| Designation |
Associate Professor, Dept of of Rognidan evum Vikruti Vigyan |
| Affiliation |
|
| Address |
OPD no 7 Rognidan vibhag
Nashik MAHARASHTRA 422003 India |
| Phone |
9272642873 |
| Fax |
|
| Email |
dr.sheetalyadav59@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Sheetal Chavan |
| Designation |
Associate Professor, Dept of of Rognidan evum Vikruti Vigyan |
| Affiliation |
|
| Address |
OPD no 7 Rognidan Vibhag
Nashik MAHARASHTRA 422003 India |
| Phone |
9272642873 |
| Fax |
|
| Email |
dr.sheetalyadav59@gmail.com |
|
|
Source of Monetary or Material Support
|
| Ayurved seva sangh ayurved mahavidyalaya Ganeshwadi panchavati Nashik 422003 |
|
|
Primary Sponsor
|
| Name |
Maharashtra University of Health SciencesNashik under the scheme of LTRG |
| Address |
Maharashtra University of Health Sciences Dindori Road mhasrul Nashik 422004 |
| Type of Sponsor |
Other [State Health University] |
|
|
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 Sheetal Chavan |
Arogyashala Rugnalaya |
OPD no 7 Rognidan vibhag Nashik MAHARASHTRA |
09272642873
dr.sheetalyadav59@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE Ayurved Seva Sangh Ayurved Mahavidyalaya Nashik |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:K87||Disorders of gallbladder, biliarytract and pancreas in diseases classified elsewhere. Ayurveda Condition: URDHVAGATA-AMLAPITTAM, (2) ICD-10 Condition:K82||Other diseases of gallbladder. Ayurveda Condition: URDHVAGATA-AMLAPITTAM, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Amlapittahar syrup, Reference: Bhavprakash, Bruhattrayi, Route: Oral, Dosage Form: Sharkara/ Syrup, Dose: 10(ml), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 1 Months, anupAna/sahapAna: Yes(details: -water), Additional Information: - | | 2 | Comparator Arm (Non Ayurveda) | | - | gelusil | gelusil syrup BD for 1 month |
|
|
|
Inclusion Criteria
|
| Age From |
19.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
patients having symptoms of Amlapitta like chardi Amlodgar Shirshul Avipak malavasthamba
Both the sex Male and Female
Patients from all socio-economical status
|
|
| ExclusionCriteria |
| Details |
Patient below 19 yrs and above 60 yrs .
patient of adhoga amlapitta
Patient having hepatic disorder and other complication
patient suffering from major illness like stomach cancer and other 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 |
| Decrease in signs & symptoms of urdhawg amlapitta. |
4 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To evaluate the efficiency of Guduchyadi Syrup for Amlapitta on Symptoms such as Aruchi, Amloudar ,Avipak,Chhardi, Ridhyadaha Do |
15 months |
|
|
Target Sample Size
|
Total Sample Size="120" Sample Size from India="120"
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 |
|
Date of First Enrollment (India)
|
20/08/2025 |
| 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="0" 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
|
Being healthy is the best and most important aspect of human life It is also possible using Ayurvedic concepts, People are sometimes affected with various types of diseases throughout there lives as a result of some etiological factor Urdhwagamlapitta is one of the most common gastrointestinal diseases that we see in our daily practice There are numerous references to urdhwagamlapitta in our served samhitas. Achharya kashyapa, Charak, and sushuruta gave us a brief overview of the disease. Urdhwagamlapitta is combination of the words amla and pitta. Essentially, the abnormal quantity of pachaka pitta is increased by amla pitta. Urdhwagamlapitta is associated with hyperacidity in modem science In our Ayurvedic texts Achharya explains the fundamental concepts of health by following the principles of Dincharya, Rutucharya, and giving the fundamental fact to maintain sharir’s agni in samanya awastha. According to Ayurveda the body is the proper balance of vata, pitta and kapha When the balance of these tridoshas is disturbed it causes agni dusti and makes the body susceptible to a variety of diseases According to current statistical medical data there is a high prevalence rate of urdhwagamlapitta in all age groups and in both genders The acceptance of western lifestyle in our daily routine, in my opinion is the most likely first cause. At the moment, everyone wants to achieve their expected life goals in the shortest amount of time possible, so they work longer hours than usual. Most of them are not taking proper care of their health because, due to their hectic schedules they do not have enough time to their food and sleep Also due to consumption of fast foods junk foods cold storage foods fermented food outside foods alcohol & excess use of analgesic medicine are the causative agent for the urdhwagamlapitta Though Urdhvaga Amlapitta is not life threatening if left untreated may invite major life threatening problems It got togh impact on patient’s social life ultimately on society In short changing mode of life is ultimately resulting in many disease one of such is Urdhvaga Amlapitta. The ancient medical science Ayurveda has an answer to every critical problem Ayurveda stands apart from the rest of medical faculties with its holistic & all encompassing approach to disease management of Nidan panchak enables this science Amlapitta is composed of two words Amla Pitta. The term Amla refers to a particular type of taste equated with sour taste which causes excessive salivary secretion. Pitta is a bodily chemical substance which is mainly responsible for the maintenance of the process of digestion, transformation and transmutation Homeostasis between the doshas is disrupted as result of etiological factors discussed above resulting in agni dushi.Agni intimately related to the pitta dosha. According to some acharys, the pitta doshas amla guna and drava guna increase, causing the pitta dosha to be unable to perform its normal function As a result the dusita agni is unable to digest food property resulting in ama. In our body patients begin to experience urdhwagamlapitta -like symptoms such as udardah chardi udgar, avipika and annbhilasha According to modern science the function of parietal and thief cells increases as a result of the same etiological factor, and they begin to secrete more hydrochloric and than usual. This hypersecration causes a lower Ph in our stomach than is normal a condition known as hyperacidity The inner coating of the stomach known as the mucosal layer becomes ulcerated as a result of the high HCL content resulting in a gastric ulcer All of these factors are taken into account in acid peptic disorder (A.P.D.) When it comes to hyperacidity management in modern science, we only have a few options: market available antacid and various types of medicine These groups are commonly used in OPD practice but due to high recurrence cost and increased side effects we cannot prescribe them for Long periods of time. As a result people are beginning to see a ray of hope in Ayurveda for the treatment of urdhwagamlapitta. The treatment of urdhwagamlapitta is based on the correction of dusita agni. Are we all aware of the importance of Agni and its karma So the main goal is to create agni in samanya awastha in order to break the pitta dosha Hence today need to try research remedies which is remove the symptoms of Urdhwag Amlapitta All above circumstances lead to the thought of selecting Urdhwag Amlapitta as my research subject One has to work as per the present trend of disease & way Acharya Kashypa was the first to give description of Amlapitta along with its management Numerous drugs have been stated in Ayurvedic texts to cure this disease The tone of this study is both clinical and comparative |