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Clinical Trials/CTRI/2021/10/037529
CTRI/2021/10/037529CompletedNot Applicable

Study of Trisutra in Urdhvag Amlapitta and its management by Vasaghrita w.s.r. to Chakradatta

Mahatma Gandhi Ayurved College Hospital Research Centre Salod H Wardha1 site in 1 country60 target enrollmentStarted: October 25, 2021Last updated:

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)

Investigators

Sponsor
Mahatma Gandhi Ayurved College Hospital Research Centre Salod H Wardha
Sponsor Class
Private medical college

Study Sites (1)

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