跳至主要内容
临床试验/CTRI/2016/02/006690
CTRI/2016/02/006690已完成1/2 期

A STUDY ON PRINCIPLES OF VAISHESHIKA DARSHANA IN AYURVEDA AND ITS APPLIED ASPECTS FOR VARNAPRASADANA IN DIFFERENT PRAKRITI

IPGT RA GAU Jamnagar India1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2016年7月3日最近更新:
适应症

试验速览

阶段
1/2 期
状态
已完成
发起方
入组人数
30
试验地点
1
主要终点
Volunteers will be selected and VarnaPrasaadana will be examined on the basis of specially prepared proforma along with a detailed history

研究概览

简要总结

This study is open label clinical study to evaluate the effect of Mukhakantivardhaka lepa and Patoladi Ghanavati on Twak vaivarnya

Special scoring scale has been prepared.

Plan of study and design:-

A special research proforma will be prepared for the assessment of the Varnaprasadana. Persons will be treated by Mukhakantivardhaka Lepa and Patoladi Ghana vati.

Design selected for this study is Open Randomized Clinical Trial Study.

Criteria for selection of patients:-

Volunteers will be selected from campus of I.P.G.T. & R.A, Jamnagar.

Inclusion criteria:

  1. Persons having age between 16 yrs to 40 yrs of different prakriti (of either sex, religion etc.)

Exclusion Criteria:

1.      Persons having Twakvaivarnya as the symptom of major systemic disease or as a result of side effect of any drugs were not selected.

2.      Persons having any Allergic condition will not be selected for the study.

3.      Persons having age less than 16 years and more than 40 years were excluded.

Group A (Treatment group)

Name of Drug     :  Mukhakantivardhaka lepa(Sharangadhara/uttara khanda/11)

SR.NO.

CONTENT

LATIN NAME

QUANTITY

|1

Rakta Chandana

Pterocarpus santalinus

1part

|2

Manjishtha

Rubia cordifolia

1part

|3

Kushtha

Saussurea lappa

1part

|4

Lodhra

Symplocos racemosa

1part

|5

Priyangu

Callicapra macrophylla

1part

|6

Bata

Ficus bengalensis

1part

|7

Masur

Lens culinaris

1part

Group B (Treatment group)

Name of Drug    :  Patoladi  Ghana vati (chakradatta/visarp-visphot chikitsa/22-23)

SR.NO.

CONTENT

LATIN NAME

Parts

|1

Rakta Chandana

Pterocarpus santalinus

1part

|2

Patola patra

Trichosanthes dioica

1part

|3

Nimba

Azadirachta indica

1part

|4

Mustaka

Cyperus rotundus

1part

|5

Guduchi

Tinospora cordifolia

1part

|6

Methika

Trigonella foenum-graecum

1part

|7

Katuka

Picrorhiza kurroa

1part

|8

Patha

Cissampelos pareira

1part

|9

Haridra

Curcuma longa

1part

|10

Yabasa

Alhagi camelorum

1part

|11

Haritaki

Terminalia chebula

1part

|12

Bivitaki

Terminalia bellerica

1part

|13

Amalaki

Emblica officinalis

1part

Procedure of Ghana vati:-

Coarsely powdered drugs will boil with 16th parts of water till the liquid reduce to 1/4th of original quantity. After that required amount (1/10th of ghanavati) of powder of the above drugs will be added to make Ghana vati.

Volunteers will be selected & randomly divided into two groups

Drug selection and posology:

Group A

Group B

|Name of Drug

Mukhakantivardhaka Lepa

Patolaadi Ghana vati

|Dose

Quantity sufficient

Two Tablets of 500m.g. in two divided doses ( b.i.d)With Luke warm water

|Preparation of drug

Lepa (with honey)

Ghanvati

|Route of Administration

Local Application on face

After meal

|Time of Administration

At evening

Orally

|Duration

60 days

60 days

Criteria for assessment:-.

A special scoring pattern will be developed for assessing signs and symptoms.

The improvement provided by the therapy will be assessed on the basis of signs & symptoms before and after treatment.

Volunteers will be selected and VarnaPrasaadana will be examined on the basis of specially prepared proforma along with a detailed history.

Summery of ClinicalStudy:

In clinical studysection aims and objectives of the applied clinical study, patients andmethodology, criteria for selection and assessment of the patients, divisionsof groups and drug administration there in etc. were mentioned.

Thestudy was conducted to assess the effect of Mukhakantivardhaka LepaandPatoladi Ghanavati on Tvakvaivarnya. Thepatients selected for the study were randomly divided into 2 groups viz. asshown in below table.

Tableshowing grouping for clinical study

Details

Group A

Group B

|Drug

Mukhakantivardhaka lepa

Patoladi Ghanavati

|Time

of Administration

Once daily

Twice daily

|Matra (Dose)

As per requirement

Two Tablets of 500m.g. in two divided doses ( b.i.d)With Luke warm water

|Route

External application

Orally

|Duration

8 weeks

8 weeks

|Follow up

15 Days

15 Days

|Total No. of registered  patients

31

31

|Total no. of patients completed

30

30

 Assessmentof the effect of treatment was done on the basis of the relief in the clinicalsigns and symptoms of the disease as well as improvement present in theobjective criteria.

Forthe present study 62 patients of Tvakvaivarnyawere registered and distributed. Out of these, in group A, 31 patients wereregistered, out of which 30 patients completed the therapy and 1 patientdiscontinued the therapy in between. In group B also 31 patients wereregistered, out of which 30 completed the therapy and 1 patients discontinuedthe therapy in between.

Table 1: Total effect of therapy on chief complaints of sixty patients

|Total effect of therapy

n

BT M

AT M

Percentage relief

SD

SE

W

t

P

Significant

|Group A

30

15.1

4.5

69.82

2.8

0.52

−465

−465

<0.001

HS

|Group B

30

15.3

4.7

68.98

2.2

0.41

−465

−465

<0.001

HS

|SD: Standard deviation, SE: Standard error, HS: Highly significant, BT M : Mean Before treatment, AT M : Mean After treatmen

Table 2: Total effect of therapy on associated complaints of sixty patients

|Total effect of therapy

n

BT M

AT M

Percentage relief

SD

SE

W

t

P

Significant

|Group A

30

3.6

0

100

1.2

0.22

−465

−465

<0.001

HS

|Group B

30

3.6

0

100

0.84

0.15

−465

−465

<0.001

HS

|SD: Standard deviation, SE: Standard error, HS: Highly significant, BT M : Mean Before treatment, AT M : Mean After treatment

Table 3: Overall effect on chief & associated complaints of sixty patients

|Total effect of therapy

n

BT M

AT M

Percentage relief

SD

SE

W

t

P

Significant

|Group A

30

15.1

4.5

69.82

2.8

0.52

−465

−465

<0.001

HS

|Group B

30

15.3

4.7

68.98

2.2

0.41

−465

−465

<0.001

HS

|SD: Standard deviation, SE: Standard error, HS: Highly significant, BT: Before treatment, AT: After treatment, M: Mean

Table 4: Overall effect of therapy in both groups

|Effect of therapy

Number of patients

Total (%)

|Group A (%)

Group B (%)

|Complete remission (100%)

0

0

0

|Marked improvement (>75%)

6 (20)

5 (16.6)

11 (18.3)

|Moderate improvement (50%–75%)

23 (76.6)

25 (83.3)

48 (80)

|Mild improvement (25%–50%)

1 (3.3)

0

1 (1.6)

|Unchanged (<25% or no relief)

0

0

0

conclusion

*      As per the resultsseen, both the drugs Mukhakantivardhaka Lepa and Patoladi Ghanavatihave shown better results in improving the color and decreasing the intensity ofthe dark patches in different Prakriti.

研究设计

研究类型
Interventional
分配方式
Computer generated randomization
盲法
Open Label

入排标准

年龄范围
16.00 Year(s) 至 40.00 Year(s)(—)
性别
All

入选标准

  • •Persons having age between 20 to 40 yrs of different prakriti of either sex religion etc.

排除标准

  • •Persons having Tvakvaivarnya as the symptom of major systemic disease or as a result of side effect of any drugs were not selected Persons having any Allergic condition will not be selected for the study Persons having age less than 16 years and more than 40 years were excluded Group A.

结局指标

主要结局

Volunteers will be selected and VarnaPrasaadana will be examined on the basis of specially prepared proforma along with a detailed history

时间窗: 60 days

Improvement will be assessed on the basis of Fair and lovely color grading scales

时间窗: 60 days

次要结局

  • Volunteers will be selected and VarnaPrasaadana will be examined on the basis of specially prepared proforma along with a detailed history(Improvement will be assessed on the basis of Fair and lovely color grading scales)

研究者

发起方
IPGT RA GAU Jamnagar India
申办方类型
Research institution and hospital

研究点 (1)

Loading locations...

相似试验