CTRI

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 16^th parts of water till the liquid reduce to 1/4^th of original quantity. After that required amount (1/10^th 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 Clinical Study:

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

The study was conducted to assess the effect of Mukhakantivardhaka Lepa and Patoladi Ghanavati on Tvakvaivarnya. The patients selected for the study were randomly divided into 2 groups viz. as shown in below table.

Table showing 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

Assessment of the effect of treatment was done on the basis of the relief in the clinical signs and symptoms of the disease as well as improvement present in the objective criteria.

For the present study 62 patients of Tvakvaivarnya were registered and distributed. Out of these, in group A, 31 patients were registered, out of which 30 patients completed the therapy and 1 patient discontinued the therapy in between. In group B also 31 patients were registered, out of which 30 completed the therapy and 1 patients discontinued the 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	âˆ’465	âˆ’465	<0.001	HS
Group B	30	15.3	4.7	68.98	2.2	0.41	âˆ’465	âˆ’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	âˆ’465	âˆ’465	<0.001	HS
Group B	30	3.6	0	100	0.84	0.15	âˆ’465	âˆ’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	âˆ’465	âˆ’465	<0.001	HS
Group B	30	15.3	4.7	68.98	2.2	0.41	âˆ’465	âˆ’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 (%)
Effect of therapy	Group A (%)	Group B (%)	Total (%)
Complete remission (100%)	0	0	0
Marked improvement (>75%)	6 (20)	5 (16.6)	11 (18.3)
Moderate improvement (50%â€“75%)	23 (76.6)	25 (83.3)	48 (80)
Mild improvement (25%â€“50%)	1 (3.3)	0	1 (1.6)
Unchanged (<25% or no relief)	0	0	0

conclusion

As per the results seen, both the drugs Mukhakantivardhaka Lepa and Patoladi Ghanavati have shown better results in improving the color and decreasing the intensity of the dark patches in different Prakriti.