CTRI

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CTRI Number

CTRI/2023/05/052983 [Registered on: 22/05/2023] Trial Registered Prospectively

Last Modified On:

19/05/2023

Post Graduate Thesis

Yes

Type of Trial

Interventional

Type of Study

Drug
Ayurveda
Other (Specify) [PhD study]

Study Design

Randomized, Parallel Group, Multiple Arm Trial

Public Title of Study

To rule out the effect of kaphshamak ras (Katu, Tikta, Kashay) dravyas in symptoms of kaphvruddhi

Scientific Title of Study

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

Trial Acronym

Secondary IDs if Any

Secondary ID	Identifier
NIL	NIL

Details of Principal Investigator or overall Trial Coordinator (multi-center study)

Name	Bhushan Deoraoji Mhaiskar
Designation	PhD Scholar
Affiliation	Sumatibhai Shah Ayurved Mahavidyalay
Address	Room No 7, Division: 1 Department of Samhita and Siddhant Sumatibhai Shah Ayurved Mahavidyalaya Survey No. 165-A, Malwadi Rd, Malwadi, Hadapsar, Pune, Maharashtra MAHARASHTRA 411028 India Pune MAHARASHTRA 411028 India
Phone	08983010655
Fax	08983010655
Email	dr.bhu2050@gmail.com

Details of Contact Person
Scientific Query

Name	NILESH KULKARNI
Designation	Professor
Affiliation	Sumatibhai Shah Ayurved Mahavidyalay
Address	Sane Guruji Hospital, Sumatibhai Shah Ayurved Mahavidyalaya Pune Maharashtra Survey No. 165-A, Malwadi Rd, Malwadi, Hadapsar, Pune, Maharashtra MAHARASHTRA 411028 India Pune MAHARASHTRA 411028 India
Phone	07798627823
Fax	07798627823
Email	prof.dr.nileshkulkarni@gmail.com

Details of Contact Person
Public Query

Name	Bhushan Deoraoji Mhaiskar
Designation	PhD Scholar
Affiliation	Sumatibhai Shah Ayurved Mahavidyalay
Address	Sumatibhai Shah Ayurved Mahavidyalaya Survey No. 165-A, Malwadi Rd, Malwadi, Hadapsar, Pune, Maharashtra MAHARASHTRA 411028 India Sumatibhai Shah Ayurved Mahavidyalaya Survey No. 165-A, Malwadi Rd, Malwadi, Hadapsar, Pune, Maharashtra MAHARASHTRA 411028 India Pune MAHARASHTRA 411028 India
Phone	08983010655
Fax	08983010655
Email	dr.bhu2050@gmail.com

Source of Monetary or Material Support

Sane Guruji Hospital, Sumatibhai Shah Ayurved Mahavidyalaya Survey No. 165-A, Malwadi Rd, Malwadi, Hadapsar, Pune, Maharashtra MAHARASHTRA 411028 India

Primary Sponsor

Name	Other Self BHUSHAN DEORAOJI MHAISKAR
Address	Sumatibhai Shah Ayurved Mahavidyalaya Survey No. 165-A, Malwadi Rd, Malwadi, Hadapsar, Pune, Maharashtra
Type of Sponsor	Private medical college

Details of Secondary Sponsor

Name	Address
NIL	NIL

Countries of Recruitment

India

Sites of Study

No of Sites = 1
Name of Principal Investigator	Name of Site	Site Address	Phone/Fax/Email
BHUSHAN DEORAOJI MHAISKAR	Sumatibhai Shah Ayurved Mahavidyalaya	Survey No. 165-A, Malwadi Rd, Malwadi, Hadapsar, Pune, Maharashtra Pune MAHARASHTRA	8983010655 dr.bhu2050@gmail.com

Details of Ethics Committee

No of Ethics Committees= 1
Name of Committee	Approval Status
IEC Sumatibhai Shah Ayurved Mahavidyalaya, Hadapsar â€“ Pune 411028	Approved

Regulatory Clearance Status from DCGI

Status

Not Applicable

Health Condition / Problems Studied

Health Type	Condition
Patients	(1) ICD-10 Condition:J984\|\|Other disorders of lung. Ayurveda Condition: KAPAVRUDDHIH,

Intervention / Comparator Agent

sno	Intervention/Comparator	Type	Drug-Type	Procedure Name	Details
1	Intervention Arm	Drug	Classical		(1) Medicine Name: Chitrak Bhibhtak Patala , Reference: Kaydev Nighnatu Aushadhi Varga 335/1179 Kaydev Nighnatu Aushadhi Varga 64/244 Dhanvatari Nighnatu Aushadhi Varga 50/117, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 1.5(g), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 7 Days, anupAna/sahapAna: Yes(details: -water), Additional Information: -
2	Intervention Arm	Drug	Classical		(1) Medicine Name: Chitrak , Reference: Kaydev Nighnatu Aushadhi Varga 335/1179, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 1.5(g), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 7 Days, anupAna/sahapAna: Yes(details: -water), Additional Information: -
3	Intervention Arm	Drug	Classical		(1) Medicine Name: Bhibhtak , Reference: Kaydev Nighnatu Aushadhi Varga 64/244, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 1.5(g), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 7 Days, anupAna/sahapAna: Yes(details: -water), Additional Information: -
4	Intervention Arm	Drug	Classical		(1) Medicine Name: Patala , Reference: Dhanvatari Nighnatu Aushadhi Varga 50/117, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 1.5(g), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 7 Days, anupAna/sahapAna: Yes(details: -water), Additional Information: -
5	Intervention Arm	Drug	Classical		(1) Medicine Name: Chitrak Bhibhtak , Reference: Kaydev Nighnatu Aushadhi Varga 335/1179, Kaydev Nighnatu Aushadhi Varga 64/244, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 1.5(g), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 7 Days, anupAna/sahapAna: Yes(details: -water), Additional Information: -
6	Intervention Arm	Drug	Classical		(1) Medicine Name: Chitrak Patala , Reference: Kaydev Nighnatu Aushadhi Varga 335/1179 Dhanvatari Nighnatu Aushadhi Varga 50/117, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 1.5(g), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 7 Days, anupAna/sahapAna: Yes(details: -water), Additional Information: -
7	Intervention Arm	Drug	Classical		(1) Medicine Name: Bhibhtak Patala , Reference: Kaydev Nighnatu Aushadhi Varga 64/244 Dhanvatari Nighnatu Aushadhi Varga 50/117, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 1.5(g), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 7 Days, anupAna/sahapAna: Yes(details: -water), Additional Information: -

Inclusion Criteria

Age From	16.00 Year(s)
Age To	80.00 Year(s)
Gender	Both
Details	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.

ExclusionCriteria

Details

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.

Method of Generating Random Sequence

Computer generated randomization

Method of Concealment

On-site computer system

Blinding/Masking

Not Applicable

Primary Outcome

Outcome	TimePoints
Reliving sign and symptoms of kaphvruddhi in the subjects intervened	Within One Week

Secondary Outcome

Outcome	TimePoints
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

Target Sample Size

Total Sample Size="420"
Sample Size from India="420"
Final Enrollment numbers achieved (Total)= "420"
Final Enrollment numbers achieved (India)="420"

Phase of Trial

N/A

Date of First Enrollment (India)

04/06/2023

Date of Study Completion (India)

31/12/2024

Date of First Enrollment (Global)

Date Missing

Date of Study Completion (Global)

Date Missing

Estimated Duration of Trial

Years="1"
Months="5"
Days="0"

Recruitment Status of Trial (Global)

Not Applicable

Recruitment Status of Trial (India)

Completed

Publication Details

Not Yet Published

Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?

Response - NO

Brief Summary

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 sickness due 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 lakshansâ€.

AIM AND OBJECTIVES:

Aim of study:

To compare the effect of ekalras kaphashamak rasdravya with kaphvruddhi lakshanas

OBJECTIVES OF STUDY:

1) To evalute the effect of Kaphshamak ras on kaphavruddi lakshans.

2) 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

3) To evalute ras-dosh prabhav siddhant by using Kaphshamak ras of kaphavruddhi lakshana.

4) 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*	Kaphshamak kar	Kaphshamak kar	Kaphshamak kar
*Part used*	Root	Root	Fruit except seed

Kaphshamak Ras dravya combinations in group -

No.	1	2	3	4	5	6	7
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 B	Group C	Group D	Group E	Group F	Group F
Drugs	Chitrak	Patol	Bhibhitak	Chitrak + Patol	Chitrak + Bhibhitak	Patala+ Bhibhitak	Chitrak + Patala+ Bhibhitak
Contents	3 gm	3 gm	3 gm	1.5 gm each	1.5 gm each	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	Water	Water	Water	Water	Water	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 churna Vati

2) Group B â€“ Subjects receiving Patala churna Vati

3) Group C â€“ Subjects receiving Bhibhitak churna Vati

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

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

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

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

FOLLOW UP PERIOD

Follow up period during Treatment is after 1^st, 3^th, 5^th,7^th 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 1^st, 3^th, 5^th,7^th 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 1^th, 3^th, 5^th,7^th day.

Data Collection

Statistical Analysis

Discussion

Conclusion

DRUG AND METHOD OF ADMINSTRATION

Intervention Table:

Groups	Group A	Group B	Group C	Group D	Group E	Group F	Group G
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.	1.5 gm bid, with Anupan - Water Before meal.	1.5 gm bid, with Anupan - Water Before meal.	1.5 gm bid, with Anupan - Water Before meal.	1.5 gm bid, with Anupan - Water Before meal.	1.5 gm bid, with Anupan - Water Before meal.	1.5 gm bid, with Anupan - Water Before meal.
Route of Drug	Oral	Oral	Oral	Oral	Oral	Oral	Oral
Drug Form	Churna vati	Churna vati	Churna vati	Churna vati	Churna vati	Churna vati	Churna vati
Duration	7 days.	7 days.	7 days.	7 days.	7 days.	7 days.	7 days.
Follow up period during 2 year (during Treatment)	After 1^st, 3^th, 5^th, 7^th days of completion of intervention	After 1^st, 3^th, 5^th, 7^th days of completion of intervention	After 1^st, 3^th, 5^th, 7^th days of completion of intervention	After 1^st, 3^th, 5^th, 7^th days of completion of intervention	After 1^st, 3^th, 5^th, 7^th days of completion of intervention	After 1^st, 3^th, 5^th, 7^th days of completion of intervention	After 1^st, 3^th, 5^th, 7^th 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

10. 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.