A Randomized Comparative Clinical Study On Efficacy Of Visaghna - Mahakasaya-Ghanavati And Haridrakhanda In Sitapitta In The Purview Cikitsaya Visaghnyaiva Sa Samam Labhate Narah

INTRODUCTION:

Ayurveda is an ancient system of medicine having eternal principles which are equally applicable even in current period. Although newer and newer diseases are being observed in the society due to drastically changed environmental factors, food and behavioural regimens, Ayurveda with its firm principles can deal with these new diseases using the system of diagnosis and treatment for anukta vyadhi mentioned in classical texts. Sitapitta is one of such diseases which is not mentioned in brhattrayi texts, but laghutrayi texts tried to explore its details as probably it may observed as separate disease in later time. Sitapitta is the tridosaja vyadhi in which as a result of exposure to cold air, kapha and vata dosa gets provoked and spread over the skin and internal body along with pitta[1] casing the sotha resembling with varati dasta sotha, excessive kandu, toda, cchardi, jwara and vidaha. Madhava and later authors opined that Sitapitta occurs due to vata predominant condition.[2]

Hetu, linga and ausadha are mentioned as triskandha of Ayurveda presenting three aspects applicable to entire concepts mentioned therein[3]. Application of the principle of one disease in another disease, can be thought in these three aspects. Sitapitta which is having causative factor as cold air exposure, can be treated with the principle of abhisangaja jwara wherein the disease is said to be occurred due to visa-vriksa-anila-sparsa i.e exposure to the air blowing through poisonous tree[4]. In current scenario, the air pollution causing due to continuous addition of poisonous air particles by the industrial set ups, is big issue at least in the metro cities. Exposure to such air can also be considered under the concept mentioned in abhisangaja jwara. On the basis of partially similar hetu i.e. exposure to air, principle of abhisangaja jwara can be utilized in treating Sitapitta. Abhisangaja jwara which is caused due to vata-pitta samsarga as per the *abhisangajah punarva**ta-pittabhyam[5]*and Sitapitta which is caused due to vata-pitta as per the quotations vatadhikam Sitapitta and pittena saha sambhuya, can be kept under same umbrella of hetu due to similar samavayi karana (vata-pitta) and nimitta karana (anila samsparsa). The principle of abhisangaja jwara ‘cikitsaya visaghnyaiva sa samam labhate narah’ having advice of usage of visaghna treatment can be applied to Sitapitta.

Bhesaja catuska of caraka-samhita encloses mahakasaya having wide clinical application. Visaghna mahakasayawhich consists of 10 drugs can be chosen as best choice for visaghna treatment due to its wide application Hence hypothesis is presented on the basis of these concepts in which principle of jvara is thought to be well applicable in Sitapitta.

The disease Sitapitta is often co related with a condition called Urticaria. Urticaria is an allergic reaction of the skin to a variety of exogenous and endogenous antigens. It is a common disease nowadays, characterized by pale red rashes and severe itching caused by an allergic reaction. Vascular dilatation, the resultant dermal oedema and pruritus are due to the releases of histamine and other mediators from mast cells. Although, any disease mentioned in Ayurveda cannot be completely compared in all aspects with the parallel modern disease, for the purpose to statistical analysis on the basis of objective parameters, the pathological investigations like IgE, DLC, ESR, are planned to be incorporated in the study.

Need of study:

Sitapitta  is commonly observed heath problem among society. When the modern counterpart of Sitapitta i.e. urticaria,  is compared for knowing the prevalence of the disease, it is observed that approximately 15 to 20% of the general population are found to get suffered from  urticaria at least once during their lifetime. Although persons of any age may experience urticaria and/or angioedema. This disease occurs most frequently after adolescence, with the highest incidence in young adults. The exact incidence and prevalence of chronic condition of this disease are not known, although it occurs in at least 0.1% and possibly up to 3% of the population.[6]  Though the disease is not life threatening, it makes patient worried, due to its appearance and severe pruritus. The modern medicine provides temporary symptomatic relief and patient has to take medicines for long time, which may be having some unwanted side effects. So a complete relief from the condition without its recurrence is still a question which could be sought out by  Ayurveda.

When classical texts of  Ayurveda are reviewed, Sitapitta is not mentioned in brhata trayi. so it is important to find the applicability of the principles of brhata trayi in diseases mentioned in other text books also.

Since the role of polluted air and other poisonous articles in this condition the use of *Visaghna mahakasaya Ghanavati[7]*should be better understood with respect to Sitapitta  .

Haridrakhanda is the medicine of choice in current practice as treatment of Sitapitta  .  Since it involves sugar content it is not that much suitable for the patients who are having condition of Diabetes mellitus. Since Visaghna  mahakasaya Ghanavati do not possess that much of sugar content it can be safely given to patients of Sitapitta who are also having an association of diabetes.

No study is yet carried out in showing the results of visaghna mahakasaya in Sitapitta.  Considering all above points the current study is highly needed.

Research question:

Is there any difference between the efficacy of Visaghna  - mahakasaya Ghanavati and Haridrakhanda in the context of the principle of Cikitsaya Visaghnyaiva sa samam labhate narah in the management of Sitapitta ?

Hypothesis:

Null hypothesis

There is no difference between the efficacy ofVisaghna -mahakasaya -ghanavati and Haridrakhanda in the management of Sitapittain the context of the principle of ‘Cikitsaya Visaghnyaiva sa samam labhate narah

Alternate hypothesis

There is a difference between the efficacy of Visaghna - mahakasaya -Ghanavati and Haridrakhand in the management of Sitapittain the context of the principle of ‘Cikitsaya Visaghnyaiva sa samam labhate narah

Aim

To study and compare the efficacy of Visaghna  - mahakasaya -Ghanavati and Haridrakhandin patients of Sitapittain the context of the principle of Cikitsaya Visaghnyaiva sa samam labhate narah

Objectives:

To evaluate the effect of Visaghna  - mahakasaya -Ghanavati in the management of Sitapitta .

To compare the efficacy of Visaghna  - mahakasaya -Ghanavati and Haridrakhand in the management of Sitapitta

  1) MATERIAL AND METHODS:

Literary references related to the study will be collected from the texts of Carakasamhita, Madhava Nidana, Cakradatta, Bhavaprakasa, Bhaisajyaratnavali, and Yogaratnakara their commentaries. Relevant modern literature, research journals and online sources will be accordingly referred and analysed.

A)   Selection of cases-

Population-  patients of Sitapitta visiting NIA (OPD & IPD)

Sample size –50  ( 25 each group)

Diagnostic Criteria – Sign and symptoms of Sitapittaas per classical texts.

Inclusion Criteria

Patients between the age group 18-60 years of age

Patients of either gender

The patients having classical signs and symptoms of Sitapitta .

Patients willing to participate in the clinical trial

Exclusion Criteria**-**

Patient with long term history of steroid and cytotoxic treatment

Pregnant and lactating women

Patients having concomitant illness like uncontrolled Hypertension, uncontrolled Diabetes mellitus, HIV, Malignancy, etc.

Anaphylaxis, Angioedema of the lips, tongue or larynx etc.

Withdrawal criteria:

The participant who develops any serious condition or any serious adverse effect (Necessitating hospitalization).  Patient wants to withdraw from the clinical trial due to  any reason

Selection of drug;-

Trial drugs:- Visaghna - mahakasaya [8]- Ghanavati

No

Ingredients

Botanical name

Used part

Quantity

|1.

Haridra

Curcuma longa Linn*.*

Kanda

1 part

|2.

Manjistha

Rubia cordifolia Linn*.*

Mool

1 part

|3.

Rasna

Pluchea lanceolata C.B Clarke

Patra

1 part

|4.

Shukshaila (Ela)

Elettaria cardamom Maton

Beej

1 part

|5.

Palindi(kri shnasariva)

Cryptolepis buchanana Roem & Schult

Mool

1 part

|6.

Candana(ra ktacandan)

Pterocarpus santalinus Linn.

Kandsaar

1 part

|7.

Kataka

Strychnos potatorum Linn*.*

Beej

1 part

|8.

Sirisa

Albizzia lebbeck Benth

Twak,Beej,P atra,Pushpa

1 part

|9.

Sindhuvara

Vitex negundo Linn

Patra,Mool, Beej

1 part

|10.

Slesmataka

Cordia dichotoma Forst. F.

Phala

1 part

               Compare drug: -Haridrakhanda[9]:

NO

NAME

BOTANICAL NAME

USEFUL PART

QUANTITY

|1.

Haridra

Curcuma longa Linn

Kanda

1 kudava

|2.

Trivrta

Operculina turpethum Linn

Moola twak

4 pala

|3.

Abhaya

Terminalia chebula Retz

Phala

4 pala

|4

Sita

Sa ardha prastha dwayam

|5.

Darvi

Berberis aristate DC

Moola, Kanda,Phala

1 Kola

|6.

Musta

Cyperus rotundus Linn

Kanda

1Kola

|7.

Ajavaina

Trachyspermum ammi Linn

Phala

1Kola

|8.

Ajamoda

Carum roxburghianum DC Craib

Phala

1Kola

|9.

Citraka

Plumbago zylenica Linn

Moola twak

1Kola

|10

Katu rohini

Piccorhiza kurroa Royle ex Benth

Moola

1Kola

|11

Ajaji(jirak)

Cuminum cyminum Linn

Beeja

1Kola

|12

Pippali

Piper longum Linn

Phala

1Kola

|13

Sunthi

Zingiber officinale Rosc

Kanda

1 Kola

|14

Dalacini

Cinnamomnm zeylanicum Breyn

Twaka

1 kola

|15

Tejapatra

Cinnamomnm tamala Nees & Eberm

Patra

1 kola

|16

Ela

Elettari acardamomum Maton

Beej

1 kola

|17

Vidanga

Embelia ribes Burm

Phal

1 kola

|18

Amrta

Tinospora cardifolia Willd

Kanda

1 kola

|19

Vasa

Adhatoda vasica Nees

Patra,Pushpa,Moola

1 kola

|20

Kustha

Saussurea lappa C.B Clarke

Moola

1 kola

|21

Amalaki

Emblica officinalis Gaertn

Phala

1kola

|22

Haritaki

Terminalia chebula Retz

Phala

1 kola

|23

Vibhitaki

Terminalia bellirica Roxb.

Phala

1 kola

|24

Cavya

Piper retrofractum Vahl

Phala,Moola

1 kola

|25

Dhanyaka

Coriandrum sativum Linn

Phala

1 kola

|26

Mrutta lauha

Bhasma

1kola

|27

Mrutta abhra

Bhasma

1kola

Prepaeration  of drug

The trial drugs will be prepared in GMP certified NIA pharmacy Jaipur, by classical methods.

***Visaghna 

• mahakasaya -Ghanavati:-***

The kvatha of Visaghna - mahakasaya drugs with 16 parts of water will be prepared. Then it will be heated till the formation of Ghana and after that vati will be prepared.

METHODOLOGY

Type of study – Comparative Randomized Clinical Trial (open, randomized, comparative, prospective)

Intervention-     Patients of Sitapitta –divided into two groups

GROUP A- 25 Patients  *Haridrakhand -*6 gm (divided dose) twice a day for 30 days. ,Anupana  lukewarmwater[10], Morning and Evening upto half an hour after completion of food (adhobhakta)

GROUP B- 25 Patients*- Visaghna  - mahakasaya -Ghanavati* 4 gm (divided dose) twice a day for 30 days. Anupana-water[11],Morning and Evening upto half an hour after completion of food(adhobhakta)

Follow up- every 15 days. Assessment of patients based on criteria will be done before and after the trial period

Assesment criteria:

All the patients will be assessed for relief in classical signs and symptoms and objective parameters after the completion of trial. To give objectivity to subjective classical signs and symptoms grading/scoring system will be adopted which is as follows-

Subjective parameters :

 Varati Damsta samsthana Sotha

Kandu Bahula

Toda Bahula

Chardi

Jvara

Vidaha

Scoring criteria:

Urticaria Activity Score[12]

Sr. no.

Wheals or hives

Grade

|1

None

0

|2

Mild (<20

wheals/24h)

1

|3

Moderate (21-50 wheals/24h)

2

|4

Intense or severe (>50 wheals/24h or large confluent areas of wheals)

3

Severity of itching

Sr.no

Itching

Grade

|1

No Itching

0

|2

Mild/Occasional itching

1

|3

Moderate frequent itching

2

|4

Severe frequent itching

3

|5

Very severe itching, which disturb sleep and other routine activity

4

 

URTICARIA CONTROL TEST[13] 1.
How much have you suffered from the physical symptom of the urticarial(itch,
hives(welts), and swelling) in the last four weeks?

  |Very much  0

Much           1

Somewhat   2

A little          3

Not at all    4

|2. How much was your quality of life affected by the urticaria in the last four weeks?

  |Very much  0

Much          1

Somewhat   2

A little        3

Not at all    4

|3. How often was the treatment for your urticaria in the last four weeks not enough to control your urticaria symptoms?

  |Very often   0

Often          1

Sometimes  2

Seldom       3

Not at all    4

|4. Overall how well have you had your urticarial under control in the last four weeks?

  |Not at all     0

A little        1

Somewhat   2

Well            3

Very well    4

|TOTAL SCORE:

A score of 16 indicates complete disease control . A score of < 12 on the UCT identifies patients with poorly controlled chronic urticaria (CU) , and a score of > 12 identifies those with well-controlled symptoms. An improvement in 3 points is a minimal response , and an improvement of > 6 points is a marked response.

  AYURVEDA SCORING PATTERN

Varati Damsta samsthana Sotha(Mandalotpatti) [14]

Parameters

Score

|Not present

0

|Up to 25% skin involvement

1

|25-50% skin involvement

2

|51-75% skin involvement

3

|More than 75% skin involvement

4

Kandu

 

Parameters

Score

|No

0

|Mild

1

|Moderate

2

|Severe

3

|Unbearable and disturbing routine

4

Toda :

Parameters

Score

|No

0

|Mild

1

|Moderate

2

|Severe

3

|Unbearable and disturbing routine

4

Associated symptoms like chardi, jvara, vidaha,

 

Parameters

Score

|No

0

|Mild

1

|Moderate

2

|Severe

3

|Unbearable

4

Frequency of attack

 

Parameters

Score

|No

0

|Once in 4-5 days

1

|Once in alternate day

2

|Once in daily

3

|Twice daily

4

 Objective:

IgE, DLC, ESR

STATISTICAL ANALYSIS

Subjective parameters

Wilcoxon’s paired rank test

Mann whitney U test

Objective parameters

Paired ‘t’ test

Unpaired ‘t’ test

**2)**OUTCOMES-

Primary Outcome-Change in classical symptoms of sheetpitta such as Varati damsta samsthana sotha, Kandu bahula, Toda bahula, Chardi, Jvara, Vidaha

Secondary Outcome-Change in IgE, DLC ,ESR

PROPOSED CONTENT OF DISSERTATION

The work will be presented in the form of a thesis with following contents-

Benediction

Acknowledgement

Introduction

Review of literature

I.               Ayurveda review of Sitapitta

II.             Modern review of Urticaria

III.           Drug review

Clinical Study

Observations and results

Discussion and summary

Conclusion

Bibliography

Appendix

 BIBLIOGRAPHY

Carakasamhita with Ayurvedadipika commentary, edited by Vd. J yadavji

Trikamji acarya Published by Chaukhambha Surbharti prakashan, Varanasi, Reprient edition 2019. cha chi. 3/117

Carakasamhita with Ayurvedadipika commentary, edited by Vd. J yadavji

Trikamji acarya Published by Chaukhambha Surbharti prakashan, Varanasi, Reprient edition 2019. cha chi. 3/118

Carakasamhita with Ayurvedadipika commentary, edited by Vd. J yadavji

Trikamji acarya Published by Chaukhambha Surbharti prakashan, Varanasi, Reprient edition 2019. cha sutra. 4/ 11

Carakasamhita with Ayurvedadipika commentary, edited by Vd. J yadavji

Trikamji acarya Published by Chaukhambha Surbharti prakashan, Varanasi, Reprient edition 2019 cha ni 1/30

Sri Madhavkara, Madhav Nidana Vol 2, Sitapitta  udardakothnidanam, 50/1, Vidyotini hindi commentary by Sudarshan Shastri, Chaukhambha Prakashan, Varanasi, 2014;

Sri Madhavkara, Madhav Nidana Vol 2, Sitapitta  udardakothnidanam, 50/3-5, Vidyotini hindi commentary by Sudarshan Shastri, Chaukhambha Prakashan, Varanasi, 2014;

Bhaishajyaratnavali of GovindaDasji, Sitapittaudardakota cikitsa 55/18-22, Varanasi, Chaukhamba Sanskrit Sansthan, Volume 3, Print 2009

Davidson S (2006).Davidsons principles and practice of medicine 20th edition, USA      Elseviers Health Science.

Ahmad W. Bilal, Ahmad S Mir (201) Research Methodology And Medical Statics for Ayurveda Scholar, Jaipur Ayurved Sanskrit Hindi Pustak Bhandar.

DravyagunaVijnana vol-2edition 2020 by PV Sharma

API Part I Volume 1,2,3,4,5,6

---

[1] Madhav Nidan 50/1

[2] Madhav Nidan 50/3-4

[3] Charak sutra 1/24

[4] Charak Chi. 3/117

[5] Charak nidan 1/30

[6] Diagnosis and management of urticaria in Indian settings: Skin allergy research society’s guideline-2022 Godse K, Patil A, De A, Sharma N, Rajagopalan M, Shah B, Tahiliani S, Girdhar M, Zawar V, Sangolli P, Shankar DK, Dhar S - Indian J Dermatol (e-ijd.org)

[7] Charak Sutra 4/11

[8] Charak Sutra 4/11

[9] Bhaishajya ratnavali 55/18-22

[10] Bhaishajya ratnavali 55/18-22

[11] API

[12]  Evaluation of efficacy of Navakarshik Kwath Ghan in Sheetpitta with special reference to Urticaria Rohan Rathod

[13] Reproduced from Weller K, Groffik A, Church MK, et al. Development and validation of the Urticaria Control Test: A patient reported outcome instrument for assessing chronic urticaria. J Allergy clin Immunol 2014;133:1365

[14] A Comparative Clinical Study To Evaluate The Efficacy Of Durva-Haridra Lepa And Amritadi Syrup In Sheetpitta With Special Reference To Urticaria In Children Dr. Abhishek Ghai