Skip to main content
Clinical Trials/CTRI/2024/06/069455
CTRI/2024/06/069455Not yet recruitingPhase 2/3

Clinical Study To Evaluate The Add On Effectiveness Of Apakwa Bilwa Phala Panaka As Pathya In The Management Of Amlapitta

Sri Dharmasthala Manjunatheswara College Of Ayurveda And Hospital1 site in 1 country48 target enrollmentStarted: July 1, 2024Last updated:

Trial Snapshot

Phase
Phase 2/3
Status
Not yet recruiting
Sponsor
Enrollment
48
Locations
1
Primary Endpoint
1.Hrit daha (burning sensation in heart)

Study Overview

Brief Summary

Amlapitta is a commonly encountered disease of the Annavaha Srotas. Improper food habits and busy stressful lifestyle are the main factors which have led to its increased prevalence. No medicine is equal to Ahara and is termed as Mahabhaishajya As ayurveda considers pathya itself as medicineIf a person ignores the concept of Pathya-Apathya and consumes apathya, illness will never leave the body. So only the diet is given the prime importance in the treatment of disease. The dravya used for study is apakva bilwa phala. The Deepana, Pachana and Amahara4 property of the dravya helps in overcoming the condition of amlapitta and bringing the agni to normalcy, thereby clears the basic samprapti of amlapitta wherein Agnimandya is in the initial stage. Sharkara due to its Pittahara and Dahahara karma helps in decreasing the symptoms of Amlapitta.apakva bilwa phala as its availability is throughout the year and is cost-effective, can be converted into various palatable formulations like syrup, squash.Apakwa bilwa phala majja is very difficult to extract on daily basis, so it is transformed into syrup form, which is ready to use in the form of panaka by mixing it with water which people commonly like to consume due to its taste. The present study will be an open label, double arm clinical study using the Convenience (non-random) sampling technique

A minimum of 48 subjects will be selected who are diagnosed with Amlapitta and fulfilling inclusion criteria will be recruited., 24 for each group that is for study group -24 subjects and control group - 24 subjects

Study group - Shamana chikitsa with Kamadudha rasa two tablets twice daily, before food. Along with it Apakwa Bilwa phala panaka is given in the dosage of 50ml [20ml syrup+ 30ml plain water] in empty stomach twice daily for 15 days. Data will be collected before and after the intervention.

Control group - Shamana chikitsa with Kamadudha rasa two tablets twice daily, is given before food, for 15 days. Data will be collected before and after the intervention.

Study Design

Study Type
Interventional
Allocation
Other
Masking
None

Eligibility Criteria

Ages
18.00 Year(s) to 60.00 Year(s) (—)
Sex
All

Inclusion Criteria

  • 1.The subjects of age group of 18-60 years will be selected.
  • 2.The subjects of all gender and Socioeconomic status will be selected.
  • 3.Subjects who are willing to sign the informed consent form.

Exclusion Criteria

  • 1.Pregnant and lactating mother 2.Known cases of carcinoma of throat, esophageal carcinoma, carcinoma of stomach.
  • 3.Known case of gastric and duodenal ulcer.
  • 4.Known case of Type 2 Diabetes mellitus.

Outcomes

Primary Outcomes

1.Hrit daha (burning sensation in heart)

Time Frame: 15 days

2.Kantha daha (burning sensation in abdomen)sensation in throat)

Time Frame: 15 days

3.Kukshi daha

Time Frame: 15 days

4.Tiktodgara (bitter belching)

Time Frame: 15 days

5.Amlodgara (sour belching)

Time Frame: 15 days

6.Avipaka (indigestion)

Time Frame: 15 days

7.Aruchi (tastelessness)

Time Frame: 15 days

8.Udara gourava (heaviness in abdomen)

Time Frame: 15 days

9.Utklesha (nausea)

Time Frame: 15 days

Secondary Outcomes

  • Gastrointestinal Symptom Rating Scale (GSRS Scale)(15 days)

Investigators

Sponsor
Sri Dharmasthala Manjunatheswara College Of Ayurveda And Hospital
Sponsor Class
Private medical college
Responsible Party
Principal Investigator
Principal Investigator

Dr Trishul Dev T A

Sri Dharmasthala Manjunatheswara College Of Ayurveda And Hospital, Hassan, Karnataka

Study Sites (1)

Loading locations...

Similar Trials