Study of Trisutra in Urdhvag Amlapitta and its management by Vasaghrita w.s.r. to Chakradatta
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- Effect of Vasaghrita in Urdhvag Amlapitta
Study Overview
Brief Summary
BRIEF SUMMARY ON PURPOSE -
Ayurveda is an ancient science of life that focuses on the primary goal of "Dhatushamyata"1 for living a long and healthy life. Ayurveda offers numerous concepts regarding dhatu balance and illness management, which includes three main pillars (Hetu, Linga, and Aushadha2) that aid in the understanding of disease symptoms and therapy. Hetu as causal causes, Linga as particular symptoms, and Ashudh as medication and illness therapy are the three components of the Trisutra.
BACKGROUND OF TRIAL -
Literature and Interventional study.
Study design
Literature review of Urdhavags Amlapita Clinical study
Assessment of patient as per inclusion and exclusion criteria
Inform consent
Treatment duration 14 days through oral route
vasa ghrita 10ml in the morning along with
nidanparivarjan and pathyapathya
2 visits during treatment each after 7 days
2 Follow up after 7 days each after treatment
Generation of statistical data
Statistical analysis
Discussion
Conclusion and Summary
Sampling procedure:
Simple random sampling.
Sample size (Including sample size calculation): 60 Patients.
Grouping & Posology**:**
| Group |
Sample size
Intervention
Dose and Frequency
Anupana
Duration
Follow up
|Trial drug
60
Vasaghrita 10 ml
10 ml once a day
Lukewarm water
14 Days
2 visits during treatment each after 7 days and 2 follow up each after 7 days of treatment.
Data collection tools and process: -
From the OPD & IPD of Mahatma Gandhi Ayurved college hospital and research Centre, Salod, Wardha.
Gradations of symptoms.
| Sr.no |
Sign/Symptoms
Grading
|1
Vanti -
0 absent
1 once/week or less quantity
2 2-3 times/week or moderate
3 > 3 times/week or profuse
|2
Shiroruja,
0 - Absent
1 Occasional
2 Intermittent
3 Continuous affecting routine work
|4
Kar - charandaha,
0 Absent
1 Occasional
2 Intermittent
3 Continuous affecting routine work
|4
Sarvangdaha
0 - Absent
1- Occasional
2- Intermittent
3- Continuous affecting routine work
|5
Hridkanthadaha
0 - Absent
1- Occasional
2- Intermittent
3- Continuous affecting routine work
|6
Aruchi
0- Absent
1- Occasional
2- Intermittent
3- Continuous affecting routine work
|7
Tikta - amlaudgar
0 - Absent
1- Occasional
2- Intermittent
3- Continuous affecting routine work
|8
Kandu,
0 - Absent
1- Occasional
2- Intermittent
3- Continuous affecting routine work
|9
Jvara -
0– absent
1- 99Ëš- 100ËšF
2--101Ëš-103ËšF
3 - >103ËšF
|10
Mandal
0 - absent
1 - 1-2mm
2 - up to 3mm
3 - up to 5mm
|11
Pidaka
0 - skin colour
1 - hyperaemic
2 - red
3 - dark red
FINDINGS -
Primary Outcomes:
We will see the Significant effect of vasa ghrita on Amlapitta,
Secondary Outcomes:
We will see the effect of vasa ghrita on Amlapitta all types of parameters
Study Design
- Study Type
- Interventional
- Allocation
- Computer generated randomization
- Masking
- Not Applicable
Eligibility Criteria
- Ages
- 21.00 Year(s) to 64.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •1 Patient age above 20 yrs.
- •and below 65 yrs.
- •2 both sexes will be selected.
- •3 Patient suffering from typical signs and symptoms of Amlapitta.
Exclusion Criteria
- •1 Patient age group below 20 yrs.
- •and above 65 yrs.
- •were excluded.
- •2 Pregnant and lactating mother.
- •3 Patients suffering from chronic diseases such as diabetes, hypertension, IHD, chemotherapy and major operative procedure etc., were excluded.
- •4 Irregular patients not providing proper data were excluded.
Outcomes
Primary Outcomes
Effect of Vasaghrita in Urdhvag Amlapitta
Time Frame: 2 weeks
Trial drug
Time Frame: 60
1
Time Frame: Vanti -
2
Time Frame: Shiroruja,
4
Time Frame: Sarvangdaha
5
Time Frame: Hridkanthadaha
6
Time Frame: Aruchi
7
Time Frame: Tikta - amlaudgar
8
Time Frame: Kandu,
9
Time Frame: Jvara -
10
Time Frame: Mandal
11
Time Frame: Pidaka
Secondary Outcomes
- Effect of Vasaghrita in Urdhvag Amlapitta in all types of Parameters(2 weeks)
