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