| CTRI Number |
CTRI/2024/11/076917 [Registered on: 18/11/2024] Trial Registered Prospectively |
| Last Modified On: |
15/11/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
study the effect of Amlyadhya Loham a herbo mineral formulation in Amlapitta (dyspepsia) or Hyperacidity |
|
Scientific Title of Study
|
An Analytical & Clinical Study to evaluate the effect of Amladhya Loham in Amlapitta (Dyspepsia) - An open labelled single arm study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Punya R Gangadkar |
| Designation |
2nd year BAMS student |
| Affiliation |
Sushrutha Ayurvedic Medical College and Hospital |
| Address |
Department of RSBK & Department of Panchakarma Room No 2 ground floor Sushrutha Ayurvedic Medical College and Hospital Bengaluru
Bangalore
KARNATAKA
560105
India |
| Phone |
8088694522 |
| Fax |
|
| Email |
punyargangadkar@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Punya R Gangadkar |
| Designation |
2nd year BAMS student |
| Affiliation |
Sushrutha Ayurvedic Medical College and Hospital |
| Address |
Department of RSBK and Department of Panchakarma Room no 2 ground floor Sushrutha Ayurvedic Medical College and Hospital Bengaluru
Bangalore
KARNATAKA
560105
India |
| Phone |
8088694522 |
| Fax |
|
| Email |
punyargangadkar@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Abhishek Biswas |
| Designation |
Assistant Professor |
| Affiliation |
Sushrutha Ayurvedic Medical College and Hospital |
| Address |
Department of RSBK Sushrutha Ayurvedic Medical College and Hospital Prashanti Kutriram Jodi Bingipura Jigani Bengaluru
Bangalore
KARNATAKA
560105
India |
| Phone |
9713844485 |
| Fax |
|
| Email |
deshubis@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sushrutha Ayurvedic Medical College and Hospital Prashanti Kutiram Jodi Bingipura Jigani Bengaluru Karnataka India
Pincode 560105 |
|
|
Primary Sponsor
|
| Name |
Sushrutha Ayurvedic Medical College and Hospital |
| Address |
Sushrutha Ayurvedic Medical College and Hospital Prashanti Kutiram Jodi Bingipura Jigani Bengaluru Karnataka India
Pincode 560105 |
| Type of Sponsor |
Private 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 Abhishek Biswas |
Sushrutha Ayurvedic Medical College and Hospital |
RSBK and Panchakarma OPD no. 2 ground floor Sushrutha Ayurvedic Medical College and Hospital Jigani Bengaluru
Bangalore
KARNATAKA |
9713844485
deshubis@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee (IEC) SAMCH & H-IEC |
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: Amladhya Loham, Reference: Rasendra Chintamani under Amlapitta Adhikara, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 500(mg), Frequency: tds, Bhaishajya Kal: Pragbhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: Ushna Jala), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
I. Classical Symptoms of Amlapitta
1. Aruchi (anorexia)
2. Gurukoshthatva (heaviness in abdomen)
3. Gaurav (lethargy)
4. Vibandh (Constipation)
5. Shiroruja (Headache)
6. Utklesh (Nausea)
7. Tiktamlodgar (Acid eructation)
8. Klama (exhaustion) and
9. Hrid- Kanta Daha (heartburn) will be considered for the study and examined on the basis of Dosha Dushya etc with a help of a special proforma after having a written consent.
II. Rome IV diagnostic criteria for Dyspepsia (Patients presenting with recurrent upper GI symptoms suggestive of dyspepsia for at least the past 6 months)
One or more of the following:
1. Bothersome postprandial fullness
2. Bothersome early satiation
3. Bothersome epigastric pain
4. Bothersome epigastric burning
AND
III. Patients with any of the following features will be evaluated clinically for other diagnoses with dyspepsia and will be ruled out (No evidence of systemic metabolic structural disease that is likely to explain the symptoms)
1. Signs or symptoms of GI bleeding.
2. Unexplained iron deficiency anemia.
3. Unintentional weight loss.
4. Palpable abdominal mass or lymphadenopathy on exam.
5. Family history of gastric cancer and no recent upper endoscopy.
6. Dysphagia.
7. Persistent vomiting.
|
|
| ExclusionCriteria |
| Details |
ï± Age below 18 above 60 years
ï± Volunteers with evidence of malignancy
ï± Suffering from major Systemic diseases
ï± Metabolic diseases other than Dyspepsia
ï± Chronic diseases with long run of medications
ï± Pregnant ladies & lactating women
ï± Participants currently taking medications or supplements that may affect the present study
ï± Participants currently enrolled in any other clinical trials or having participated in any other clinical trial in the past 30 days.
ï± Participants with history or currently under substance abuse.
ï± Any other conditions which investigator things may jeopardize the study.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess analytical properties & evaluate the therapeutic effects of Amladhya Loham in managing symptoms of Amlapitta (Dyspepsia). |
0 day and 31st day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. To prepare Amladhya Loham
2. Evaluate the safety of Amladhya Loham
3. Analyze the changes in symptomatology & clinical parameters of Amlapitta (Dyspepsia) using Assessment Criteria for Subjective parameters
4. Assess the reduction in frequency & severity of Dyspepsia with GSRS questionnaire
|
0 day & 31st day |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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)
|
15/01/2025 |
| 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="0"
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
|
Amlapitta (Dyspepsia) being one of the Annavaha Strotas Dushti
Vikara is a commonest disease in present era. The pooled prevalence of dyspepsia
in India is estimated to be between 7.6% to 49% of the population with
prevalence rate more in males in the age group of 35-501. The risk
factors were age, irregular food habits, tea/coffee intake, tobacco, and
alcohol consumption.2 Dyspepsia encompasses symptoms such as upper
abdominal fullness, heartburn, nausea, belching, and upper abdominal pain,
often occurring after eating or drinking. Although typically not
life-threatening, these symptoms can significantly impact an individual’s
quality of life. Prolonged reliance on antacids can have detrimental effects,
leading to constipation and potentially serious complications like
neurotoxicity over time. If left untreated, dyspepsia can lead to serious
complications making treatment more challenging.
According to Ayurveda Mandagni
(weak digestive fire), which negatively affects the Samana and Udana
Vayu, as both Vayu are responsible for proper digestion. The
excessive consumption of Amla (sour), Katu (spicy), Ushna
(hot), and Viruddhashana (incompatible food combinations) leads to an
aggravation of Pitta Dosha & gets converted into Amla Rasa
(sour taste), resulting in Amlapitta.3,4
Considering its severity &
serious complications; a combination of herbo-mineral cost-effective
formulation i.e. Amladhya Loham mentioned in Rasendra
Chintamani under Amlapitta Adhikara5 which has
been said as Maha Amlapitta Nashaka is taken for study. The key
ingredients, Amlaki has anti-spasmodic, anti-ulcer actions6,
Pippali corrects the Apakva Pitta & has Vatanulomana
action7, Loham Bhasma reduces acidic secretions, improves
bowel movement8, and Sharkara Churna is Ruchya
& also has properties like Daha Hrut, Vata Pittahara9,
work synergistically to alleviate Pitta Dosha, correct Agni,
and aid in Shamana of Amlapitta (Dyspepsia).
To check the authenticity of
the formulation for its further broader usage in the market analytical
study is planned. |