临床试验/CTRI/2023/05/052983

CTRI/2023/05/052983尚未招募不适用

Evalution of the concept of ras-dosh sambandh siddhant by using kaphshamak ras (Katu, Tikta, Kashay) dravyas in kaphvruddhi lakshanani

Other Self BHUSHAN DEORAOJI MHAISKAR1 个研究点分布在 1 个国家目标入组 420 人开始时间: 2023年4月6日最近更新: 2023年5月19日

试验速览

阶段: 不适用
状态: 尚未招募
发起方
入组人数: 420
试验地点: 1
主要终点: Reliving sign and symptoms of kaphvruddhi in the subjects intervened

研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

Brief Summery:

Ayurveda aims at prevention and cure of diseases. Acharya Sushruta defined â€œAarogyaâ€ as equilibrium or balanced state of dosha, agni, dhatu and mala, pleasant state of atma, indriya and mana is healthy state. [1]

The basic concept of Ayurveda is doshman. This Siddhanta provides fundamental knowledge for understanding of the theories of Ayurveda regarding Ahara pachana*,* Dhatu Utpatti*,Vyadhi Utpatti,* Ayu parigyana etc. With the help of that particular doshman, the body gets its samprapti by serial development of diseases. This can be understood in the terms of dosh how its vitiated and what are the possible management of it. It is quite clear that we simple approach the symptoms so that even donâ€™t need to be having whole disease management, therefore a Vaidya should always take care of doshman which is least examined in course of treatment

Any disturbance in the equilibrium of dosh is known as disease and on the other hand the state of their equilibrium is health. [3] According to charak Samhitas â€œkaphavruddhiâ€ is the basic cause for kaphjanya pathogenesis of disease. [4]

2.Literary review**:-**

a) Concept review:-

The concept of ras-dosha sambhandh is unique [4] and if one wan to manage the disease we must know pre-symptoms, sign and symptoms, upshay, sankhya, pradhanya, vidhi, vikalp, bal, kal vishesh, type of samprampti then we one know dosh as first priority, later aushdh, desh kal,bal, sharer, sar ahar, satmya, satwa. A vaidya must know all by just how itâ€™s vitiated at extent it vitiated, treatment of any disease and symptoms is purely depedent on doshman.then its very easy to manage every thing.

Acharya Charak has mentioned that before management one should follow type of dosha which is involved in samprapti. By just knowing the exactly at what extent its vitited or mitiated. In rasviman addhay[6], Acharya charaka mentioned that, ekek dosha its to be formed by ek ek ras in the process of digestion. While katu, kashay and tikta ras aggrevates vatdosha, madhur amla lavan mitiates vaatdosha. Katu amla lawana ras aggrevates pittadosha while madhur tikt kashay mitiates pitta dosha, madhur amla and lawan ras aggrevates the kapha dosha while katu tikta kashay mitiates kapha dosha. [5] This main principle of management of disease by simple way approaches its pre- symptoms and symptoms.

STUDY RATIONALE

Doshman of any disease is simple way to approach a disease. Doshman gives a idea at what extent dose samprapti of dosha happens. There is co-realation between ras and dosh. Dravya are classifies o the basis of their ras-dosh prabhav. Itâ€™s extent of choosing for management of disease.

1) In ayurveda we should follow the ras-dosh relation without knowing samprapti.

2) Dravya take part into action with pradhan ras, dravya acts by ras parbhav and hence use of Kaphashamak ras is treat the kaphavruddhi in any disease.

3) Kaphashamak ras and its sanyog is best treatment for kaphavruddhi lakshans.

4) Kaphashamak ras and its sanyog acts by its panchbhautik sanghtan and act on kaphavruddhi. Production of excess â€œkaphâ€ a main cause of sicknessdue to kaphavruddhi, root cause of all diseases is kaphavruddhi its simple to treat by selecting type of ras dravya.

Ahar Hetu

Vitiation of dosha by ras

kaphavruddhi dosh utpatti

kaphavruddhi janya lakshan utpatti

kaphavruddhi janya vicar utpatti

Thus deciding the dosh man which vitiated which affects body balance is of prime importance, to assess healthy and unhealthy state. Subjective parameters for assessment of kaphavruddhi mentioned in classical text.

PROBABLE MODE OF ACTION

Kaphashamakkar ras (Katu Tikta Kashay Ras-dosh Parbhav)

Kaphashaman

Mitiation of kapha vudhh lakshan

REVIEW OF LITERATURE:-

à¤¶à¤®à¤¯à¤¨à¥à¤¤à¤¿****||à¥¬|| Ch.Sa.Vi1/6

Indications of use of Kaph shamak ras dravya in the management of Kaphvrudhi lakshanas.

Chakrapani.

Action of dravya are mainly due to ras as its main content.

As.Hri. Drav-Drav vigyaniyam 9

Taste in a substance also arises out of Pancha mahabhuta (5 element) combination. Hence, because of the combination of the elements, there is no substance having only one taste. Similarly, there is no disease arising out of a single Dosha. Any disease will have involvement of more than one Dosha.

A.Hri. Sutra.11/13

Kapha, when increased produces, Agnisadana â€“ weak digestive activity,, Praseka â€“ excess salivation, Alasya â€“ lassitude, laziness, Gaurava â€“ feeling of heaviness, Shvaithya â€“ white discoloration, Shaithya â€“ coldness,, Shlathangatva â€“ looseness of the body parts, Shwasa â€“ dyspnoea, Kasa â€“ cough, Atinidrata â€“ excess of sleep. 7 â€“ 7Â½.

RESEARCH QUESTION:-

â€œKaphshamak ekal ras and ras sanyog is effective in the management of *Kaphvruddhi lakshans.*â€

ALTERNATE HYPOTHESIS: -

There is relationship between â€œKaphshamak ekal ras and its ras dravya sanyog prabhav with Kaphavruddhi lakshansâ€™â€™

NULL HYPOTHESIS: -

There is no relationship between â€œKaphshamak ekal ras and ras sanyog prabhav with Kaphavruddhi lakshans**â€.

AIM AND OBJECTIVES:

Aim of study:

To compare the effect of ekalras kaphashamak rasdravya with kaphvruddhi lakshanas

OBJECTIVES OF STUDY:

To evalute the effect of Kaphshamak ras on kaphavruddi lakshans.
To evaluate the effect of Kaphshamak rasdosha prabhav in the management of kaphavruddhi lakshana.

3) To compare the effect of combinations of kaphashamak ras on kaphvruddhi lakshan

To evalute ras-dosh prabhav siddhantby using Kaphshamak ras of kaphavruddhi lakshana.
To study the interrelationship between Kaphshamak rasdravya and its ras sanyog prabhav with Ras dosh prabhav.

PREVIOUS WORK DONE:-

1) Neera Saini, Pradeep Kumar Pal and P.S. Byadgi Critical Analysis of Etiological Factors of Ajirna, IJCAM 05 00141, Volume 5 Issue 1 â€“ 2017.

2) Dr. Sudhir. L. Lad, Study Of Kiratadhya Churna In Grahani Vyadhi, International Journal of Advancements in Research & Technology, Volume 2, Issue 11, November-2013.

3) Wangle magala dilip, Importance of agni (digestive fire) in the mangment of grahani disease, with special reference to lawanbhaskara churna in grahani roga (Small intestine Disease) inter.J.Res. ayurveda pharm.4 (4), July-Aug.2013.

4) Dr. Subhash Chandra, Dr. Rashmi Gurao, Dr. O.P Dadhich Conceptual Study Of Hypothyroidism And Agnimandya International Journal of Ayurvedic and Herbal Medicine 5:4 (2015) 1923â€“1931.

5) Fundamental and Applied aspect of Lifestyle in Ayurveda classics and its role in Amajirna, Deshmukh Saylee H . April â€“ 2014, IPGTRA, Jamnagar.

6) Madankar Mandarkumar et al: A Survey Study of the Prevalence of Various Diseases in Yamdanshtra Kala (Period between Nov-Dec), IAMJ: Volume 3; Issue 3; March- 2015.

7) An applied study of interrelationship of Jatharagni and dhatvagni in context to DhatuvÅ—ddhi, Dr Kishor g. Satani, Jamnagar, march â€“ 2012.

8) Byadgi P S et al, IJRAP, An insight into the understanding of agni and its clinical importance, 2011, 2(6) 1637-1641.

Material and Methods:

Materials:

1) Participants: - Subjects with Kaphvruddhi lakshans will be randomly selected from the OPD and IPD of Hospital

2) Drug Review:-

Kaphshamak Ras dravya


Dravya

Chitrak [7]

Patala*[8]***

Bhibhitak[9]

|Latin Name / Chemical name

Plumbago

zeylanika

Linn*.*

Steriospermum suaveolens

Linn*.*

Terminalia

belerica Linn*.*

|Ras

Katu

Titka, kshay

Kashay

|Doshkarma

Kaphshamakkar

Kaphshamak

kar

|Part used

Root

Fruit except seed

Kaphshamak Ras dravya combinations in group -


No.

|Dravya

sanyog

Ek Ras

dravya

Ek Ras

dravya

Ek Ras

dravya

Dvay Ras

dravya

Dvay Ras

dravya

Dvay Ras

dravya

Tray

Ras dravya

|Group

Group A

Group

Group D

Group

|Drugs

Chitrak

Patol

Bhibhitak

Chitrak + Patol

Chitrak + Bhibhitak

Patala+ Bhibhitak

Chitrak +

Patala+ Bhibhitak

|Contents

3 gm

1.5 gm each

0.66 gm Each

|Dose

3 gm

Vati (500mg each)

3 gm

Vati (500mg each)

3 gm

Vati (500mg each)

3 gm

Vati (500mg each)

3 gm

Vati (500mg each)

3 gm

Vati (500mg each)

3 gm

Vati (500mg each)

|Anupan

Water

|Kal

Anannakal

(Before meal)

Anannakal

(Before meal)

Anannakal

(Before meal)

Anannakal

(Before meal)

Anannakal

(Before meal)

Anannakal

(Before meal)

Anannakal

(Before meal)

Methodology

Study design -. Comparative Clinical Seven arm study.

Type of study - Prospective Interventional study

Study Area â€“ OPD/IPD of College hospital.

Study Duration â€“ 1.5 years

Sample size: 420, (60 patients in each group)

Type of Sampling â€“ Purposive sampling

Method of Selection of Patients

Grouping:- Dosh pariksha of all the selected subjects will be done on the basis of subjective parameters (Case Report Proforma). Then Cardinal signs and symptoms of kaphvrudhi will be identified. Accordingly all the participants will be divided equally in seven groups.

1) Group A â€“ Subjects receiving Chitrak churnaVati

2) Group B â€“ Subjects receiving Patala churnaVati

3) Group C â€“ Subjects receiving Bhibhitak churnaVati

4) Group D â€“ Subjects receiving two drug combination Chitrak + PatalaVati

5) Group E â€“ Subjects receiving two drug combination Chitrak + BhibhitakVati

6) Group F â€“ Subjects receiving two drug combination Patala+ BhibhitakVati

7) Group D â€“ Subjects receiving Three drug combination Chitrak + Patala+ BhibhitakVati

FOLLOW UP PERIOD

Follow up period during Treatment is after 1st, 3th, 5th,7th day of completion of intervention. Subjects kept on routine diet, to avoid Kaphvrudhhikar ahar with pathyapathya palan.

ASSESSMENT PERIOD

Signs and symptoms of kaphvruddhi lakshana are assessed on the 1st, 3th, 5th,7th day

Case Definition: -Subjects Satisfying inclusion criterion having cardinal signs and symptoms of kaphvrudhhi of either gender between age group 16-50 yrs.

Inclusion criteria:

1. Subjects of either gender between age group 16-50 yrs will be selected.

2. Cardinal signs and symptoms of *Kaphvruddhi (*Agnisadana, Praseka Alasya, Gaurava, Shvaithya, Shaithya, Shlathangatva, Shwasa, Kasa, Atinidrata)

3. Obedient and regular in attending or reporting the OPD & IPD patients.

Exclusion criteria:

1. Subjects having sign and symptoms other than Kaphvriddhijanya vikar.

2. Patients known case of tuberculosis, carcinoma of stomach and intestine etc.

3. Subjects with addiction of alcohol, tobacco, smoking, kharra, mava etc.

4. Pregnant woman and lactating mothers.

5. Subjects performing night duty shifts.

Withdrawal criteria:

1. Patients willing to quit in between the trial will be allowed to quit and replaced.

2. If any adverse effect and drug reaction develops patients excluded.

Drug Standardization:

All Raw materials used in trial in crude form will be collected from genuine source. They Will be Authenticated and standardized.

Preparation of Drug:

Preparation of Churna vati will be prepared is done in attached pharmacy.

Study Plan: -

Seven Arm Clinical trial

Screening of patients

Patient Satisfied Inclusion criteria Patient Satisfied Exclusion criteria

(Yes) (Yes)

Counseling Patient will be excluded

Initial Assessment

Cases will be recorded in CRF

Written Informed consent taken

Randomization in seven groups (Purposive random sampling)

Drug Intervention

Rescue Medicine given if required.

Assessment done every 1th, 3th, 5th,7th day.

Data Collection

Statistical Analysis

Discussion

Conclusion

DRUG AND METHOD OF ADMINSTRATION

Intervention Table:


Groups

Group

Group C

Group D

Group E

Group F

Group

|Sample size

Will be decided

after pilot study

Will be

decided

after pilot study

Will be decided

after pilot study

Will be

decided

after pilot study

Will be decided

after pilot study

Will be

decided

after pilot study

Will be

decided

after pilot study

|Intervention

Chitrak churna Vati

Patala churna**Vati

Bhibhitaka churna**Vati

Chitrak churna + Patala churna**Vati

Chitrak churna + Bhibhitaka churna**Vati

Patala churna + Bhibhitaka churna**Vati

Chitrak churna + Patalachurna + Bhibhitaka 0.66gm each**Vati

|Dose

1.5 gm bid, with Anupan - Water Before meal.

|Route of Drug

Oral

|Drug Form

Churna vati

|Duration

7 days.

|Follow up period during 2 year (during Treatment)

After 1st, 3th, 5th, 7th days of completion of intervention

Assessment criteria

Parameters for Subjective Criteria

Symptoms of Kaph dosh vrudhhi

1. Agni sadan

2. Prasek

3. Alasya

4. Gaurav

5. Shvaithya â€“ white discoloration,

6. Shaithya â€“ coldness,

7. Shlathangatva â€“ looseness of the body parts,

8. Shwasa â€“ dyspnoea

9. Kasa â€“ cough, cold

Atinidrata â€“ excess of sleep. 7 â€“ 7Â½.

Subjective Parameters

Kapha vruddhi lakshana assessment


Sr. No.

Criteria

Gradation

Follow-up

|Before

Treatment

Day1

Day15

Day30

|01

Agni-sad

(Loss of Appetite)

Absent - 0

|Mild - 01

(Mild Appetite)

|Moderate - 02

(Moderate Appetite)

|Severe - 03

(Loss of Appetite)

|02

Prasek

(Water Eructations)

Absent - 0

|Mild - 01

(Alpa Prasek)

|Moderate - 02

(Madhyam Prasek)

|Severe - 03

(sampurn Prasek)

|03

Alasya

(Lassitude at the

somatic as well as

psychological

level)

Absent - 0

|Mild - 01

(Mild Lassitude)

|Moderate - 02

(Moderate Lassitude)

|Severe - 03

(Higher Lassitude)

|04

Sharir Gaurava

(Feeling of Heaviness)

Absent - 0

|Mild - 01

(Alpa Gaurav)

|Moderate - 02

(Ekang Gaurav)

|Severe - 03

(Sarvang Gaurav)

|05

Shvaithya

(White discoloration)

Absent - 0

|Present â€“ 01

|06

Shaithya

(coldness)

Absent - 0

|Present â€“ 01

|Shlathangatva â€“ (looseness of the body parts)

Absent - 0

|Present â€“ 01

|07

Shwasa

(dyspnoea),

Absent - 0

|Present â€“ 01

|08

Kasa â€“ cough, cold

Absent - 0

|Present â€“ 01

|09

Atinidrata â€“ excess of sleep. 7 â€“ 7Â½.

Absent - 0

|Present â€“ 01

|Apla -02

|Ati â€“ 03

Parameters for Objective Criteria. - Nil

Case Record Proforma: - Case Record Proforma will be prepared for assessment of kaph vruddhi lakshan , sign and symptoms of kaph vruddhi (attached in annexure)

Routine investigations:

Assessment of kaphavruddhi lakshan, (Through CRF)

Specific investigations: Nil

PICO MODEL


Population

Subjects of either gender between age group 16-50 yrs

|Intervention

Group A - Chitrak Churna (katu)

Group B - Patala(Tikta)

Group C - Bhibhitak (Kashay)

Group D - Chitrak Churna (katu)+ Patala(Tikta

Group E - Patala(Tikta)+ Bhibhitak (Kashay)

Group F - Chitrak Churna (katu+ Bhibhitak (Kashay)

Group G- Chitrak Churna (katu)+ Patala(Tikta)+ Bhibhitak (Kashay)

|Comparison

Subjects of Group A will be compared on assessment criteriaâ€™s with Group B, Group C, Group D, Group E, Group F, and Group G vice versa before and after intervention.

Â· Kaphvruddhi lakshan parikshan.

|Outcome

Â· Reliving in sign and symptoms in the subjects intervened.

Â· Correlation between Ras dosh on the basis of Subjective parameters of Kaphshamak Ras dravya.

Â· Transitory scale of assessing Ras-dosha prabhav by choosing type of ras.

Â· Founding new drug Intervention which effective on to doshlakshans by choosing on type of dravya.

研究设计

研究类型: Interventional
分配方式: Computer generated randomization
盲法: Not Applicable

入排标准

年龄范围: 16.00 Year(s) 至 80.00 Year(s)（—）
性别: All

入选标准

•Subjects of either gender between age group 16-50 yrs will be selected.
•Cardinal signs and symptoms of Kaphvruddhi (Agnisadana, Praseka, Alasya, Gaurava, Shvaithya, Shaithya, Shlathangatva, Shwasa, Kasa, Atinidrata).
•Obedient and regular in attending or reporting the OPD & IPD patients.

排除标准

•Subjects having sign and symptoms other than Kaphvriddhijanya vikar.
•Patients known case of tuberculosis, carcinoma of stomach and intestine etc.
•Subjects with addiction of alcohol, tobacco, smoking, kharra, mava etc.
•Pregnant woman and lactating mothers.
•Subjects performing night duty shifts.

结局指标

主要结局

Reliving sign and symptoms of kaphvruddhi in the subjects intervened

时间窗: Within One Week

次要结局

Effect of Katu, tikta, kashay dravya in either single or different combination form on Kaphvruddhi Symptoms.(At the baseline, 3rd Day, 5th Day,7th Day,9th Day)

研究者

发起方

Other Self BHUSHAN DEORAOJI MHAISKAR

申办方类型

Private medical college

研究点 (1)

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