Effect of Ayuevedic Medicine in VARNA PRASADANA
- Conditions
- Vaivarnya
- Registration Number
- CTRI/2016/02/006690
- Lead Sponsor
- IPGT RA GAU Jamnagar India
- Brief Summary
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 Lepa*and*Patoladi* *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 *Tvakvaivarnya*were 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 Ghanavati*have shown better results in improving the color and decreasing the intensity ofthe dark patches in different *Prakriti*.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 30
Persons having age between 20 to 40 yrs of different prakriti of either sex religion etc.
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Volunteers will be selected and VarnaPrasaadana will be examined on the basis of specially prepared proforma along with a detailed history 60 days Improvement will be assessed on the basis of Fair and lovely color grading scales 60 days
- Secondary Outcome Measures
Name Time Method 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
Trial Locations
- Locations (1)
OPD No 18 IPGT & RA Hospital GAU Jamnagar
🇮🇳Jamnagar, GUJARAT, India
OPD No 18 IPGT & RA Hospital GAU Jamnagar🇮🇳Jamnagar, GUJARAT, Indiamadhumita panigrahiPrincipal investigator7048653583drmadhumit.panigrahi@gmail.com