“An open level Comparative Clinical Study to Evaluate the Efficacy of Parijata Kashaya with and without Snigdha Agni Karma in Gridhrasi vis-a-vis Sciatica”

Synopsis Submitted to

Sri Sri University,Cuttack

(Faculty of Health and Wellness)

 

For the Degree of Ayurveda Vidya Varadhi (Ph.D.) In

Kaya chikitsa

   Submitted by

Dr.Ajay Kumar Dharmabrat Acharya

PhD Scholar

Dept of Kayachikitsa

SSCASRH, SSU

 

Guide

Prof. (Dr). Nagendra Prasad

Professor & HOD  

Department of Sharira Kriya Vignana

SSCASRH, SSU

 

 

Sri Sri College of Ayurvedic Science and Research Hospital, Sri Sri University, Cuttack 2022-2025

SUBMISSION OF RESEARCH PROPOSAL

 

Sl. No.	Particulars of Proposal Submitted
1.	Course	PhD in Ayurveda- Kayachikitsa
2.	Scholar	Dr. Ajay Kumar Dharmabrat Acharya Contac no-9108210440 REG. NO. SSU-2022-00753 Email id- ajayacharya010.aa@gmail.com/  dr.a2022-23ds@srisriuniversity.edu.in
3.	Batch	2022-23
4.	Guide	Prof. (Dr). Nagendra Prasad HOD, SKV, SSCASRH, SSU Contact No. 9743634751 E-Mail: drprasadng@gmail.com
5.	“Workshop on Good Clinical Practice” as per ICMR Guideline 2017	Attended on 8th April 2024 (Certificate of Participation attached)
6.	Title Of Synopsis	“An open label Comparative Clinical Study to Evaluate the Efficacy of Parijata Kashaya with and without Snigdha Agni Karma in Gridhrasi vis-a-vis Sciatica”

 

 

 

 

 

 

 

 

 

INTRODUCTION

‘Ayurveda’ is natural healing system of medicine “to maintain health of a healthy person and curing the ailments of an unhealthy person”. Change in life style in developing countries has created several disharmonies in biological system. Factors like improper sitting-sleeping postures, jerking movements in travel & sports activities lead to the low back pain & sciatica due to pressure on spine. Likewise, progressive disorders affecting the pelvis and nearer structures are also precipitating this condition.

Ø Sciatica has some unique epidemiologic characteristics like

•         No gender predominance

•         Lifetime incidence is reported to be between 10% to 40%

•         An annual incidence of 1% to 5% (about 40% of population)

•         No association with body height

•         It rarely occurs before age 20 unless secondary to trauma

•         Physical activity increases incidence

•         Occupational predisposition has been shown in machine operators, truck drivers, and jobs where workers are subject to physically awkward positions. ⁽¹⁾

Gridharsi is one among the Vataja nanatmaja vyadhi ⁽²⁾. The cardinal signs and symptoms are Ruk, Toda, Sthambha, Muhur spandana in Sphik Poorvam, Kati, Prishta, Uru, Janu, Janga, Pada ^[3] in order and Sakthinikshepa Nigraha ⁽⁴⁾ i.e. restricted lifting of leg. In Kaphanubandha Rogi, Tandra, Gourava, Arochaka⁽⁵⁾ will be present. It occurs because of sciatica nerve irritation and characterized by pain in distribution of sciatic nerve. Sciatica is more common between 30 and 50 years of age. ⁽⁶⁾ Pain in sciatica is very severe, which makes the patient difficult to walk; hampering the daily routine of the individual. In conventional method like analgesics, epidural steroid injection, peri-radicular infiltration and surgical treatment. All these modalities have their own limitations and complications for temporary relief of pain,

Ayurveda is one of the best ways to treat gridhrasi without any further complication in the recent past.  As Sciatica resembles the disease Gridharsi in Ayurveda, so there is different way to treat this disease. For this purpose, this study is designed like ‘A Comparative Clinical Study to Evaluate the Efficacy of Parijata Kashaya with and without Snigdha Agni Karma and in Gridhrasi vis-a-vis Sciatica.

 

NEED FOR THE SELECTION OF THE TOPIC

 

·        After review of previous studies, it was observed that some formulations and procedures have been established to restrict the progression of gridhrasi (sciatica) with certain limitations.

·        The requirement of a non-toxic, potent, cost effective, easily available, grdhrasihara procedure/ drug.

·        Therefore, in this study an attempt will be made to establish the efficacy of snigdha agni karma and parijata kashaya in the management of gridhrasi (sciatica).

 

PRIMARY RESEARCH QUESTION

 

·        Is there any effect of snigdha agni karma in the management of gridhrasi (sciatica)?

 

AIM AND OBJECTIVES

 

Aim

•      To assess the clinical efficacy of Parijata kashaya in Gridhrasi vis-a-vis Sciatica

•      To assess the clinical efficacy of Parijata kashaya and Snigdha Agni Karma in Gridhrasi vis-a-vis Sciatica

 

 

 

Objectives

•      To evaluate the clinical efficacy of Parijata kashaya in Gridhrasi vis-a-vis Sciatica.

•      To evaluate the clinical efficacy of Parijata kashaya and parijata kashaya with snigdha agni karma in Gridhrasi vis-a-vis Sciatica.

Funding Agency (if any):

·        All the expenditures during the study will be borne by the principal investigator.

 

PREVIOUS WORKS DONE

 

1.     International Research Journal of Ayurveda & Yoga, Effect Of Dasamuladi Yog And Snigdha Agnikarma In Management Of Gridhrasi(sciatica), Pratibha Sarmah1, Bishnu Prasad Sarma2, Ranjan Kalita3, Vol. 5 (6),15-23, June, 2022, ISSN: 2581-785X; Https://Irjay.Com/, DOI: 10.47223/Irjay.2022.5602

2.     Dr Vaneet Kumar, A comparative clinical study of Agnikarma and Siravedha in the management of Gridhrasi w.s.r. Sciatica, Department of Shalya Tantra Institute for Postgraduate Teaching and Research In Ayurveda, Gujarat Ayurved University, Jamnagar, 2013

3.     Sapana S. Dakhole, Brijesh R. Mishra, Harish J. Purohit. Systemic review on Gridhrasi management by Parijata (Nyctanthus arbortristis). J Ayurveda Integr Med Sci 2022; 7:138-141.

 

HYPOTHESIS

 

H₀-Neither Parijata kashaya nor Snigdha Agni Karma are effective in Gridhrasi vis-a-vis Sciatica.

H₁-The clinical efficacy of Parijata kashaya is more significant than Snigdha Agni Karma in Gridhrasi vis-a-vis Sciatica.

H₂-The clinical efficacy of snigdha agni karma is more significant than parijata kashaya in Gridhrasi vis-a-vis Sciatica.

H₃-The clinical efficacy of snigdha agni karma with parijata kashaya is more significant than the efficacy of snigdha agni karma and parijata kashaya.

 

MATERIALS AND MATHODS

 

Plan of study

 

·        Registration and Ethical clearance: The study will be registered in CTRI after its ethical clearance before enrolment of patients.

·        Screening of Patients: Presence of gridhrasi (sciatica) will be established based on the clinical sign and symptoms.

·        Enrolment of patients: All the eligible subjects will be enrolled in prescribed case sheet after taking written consent from them.

·        Recruitment: Patients will be recruited by computerized algorithm for random allocation into two groups of 60 patients in each.

·        Time duration till follow up: The patient will be studied for a total duration of 60 days and will be followed up on day 31^st, and 61^st day.

·        Time schedule of interventions: Drugs and procedure will be given from 0 to 30 days.

·        Place of Research: Place of Research will be at SSCASRH, SSU, Cuttack, Odisha.

·        Trial design: Randomized controlled clinical trial.

·        Duration of Research Project: 1 year 6 months

·        Masking/blinding: No blinding

·        Study Population:150

·        Sample size :90

Selection Criteria:

·        Age- 20 to 60 years

·        Sex- Both genders

·        Diagnosed Patients from OPD and IPD of SSCASRH, SSU, Cuttack and OPD and IPD of my work place, Ashwini Ayurvedic Medical College & Research Center, Tumkur will be selected irrespective of gender and religion.

 

Diagnosis: Diagnosis will be made as per clinical findings and investigation outcomes for organ evaluation.

1.       CBC

2.       LFT

3.       KFT

4.       Lipid Profile

5.      HbA1c

 

INCLUSION & EXCLUSION CRITERIA

Inclusion Criteria

•      Patient having Classical symptoms of gridhrasi that pain starting from hip radiating down to back of thigh, knee, leg and foot.

•       Age group between 20 to 60 years.

•       Positive SLR test

•      positive Bragard’s test

Exclusion Criteria

•      Diabetic patients, any type of skin infection

•       Patient below 20 years and above 70 years age.

•       Cases of spondylolisthesis, pregnancy and lactating mothers

•      Diagnosed case of bone TB, bone CA, tumor or cyst compressing nerve root.

•       Patient having, fracture vertebrae, destructed vertebral bodies.

•      Patients who are unfit for Agni karma

 

Criteria for Discontinuing or Modifying Allocated Interventions

•      If patient develop any acute illness.

•       Discontinuation of Drug/Procedure during trial.

•       Participants developing any complications.

•       If IEC will advise to terminate the study at any point of time.

 

ASSESSMENT CRITERIA:

·        Clinical Assessment: Clinical assessment will be done on both subjective and objective parameters at day 0^th , 31^st, 61^st day.

·        Assessment of Efficacy: Assessment of efficacy will be noted in every visit by observing improvement in clinical sign and symptoms along with SLR Test & Bregard’s Test.

·        Assessment of Safety: No adverse effect of the drug has been reported. GCP safety guidelines will be followed to assess the safety during clinical trial.

·        Overall Tolerability Evaluation: The tolerability to the intervention of the subject will be noted in every visit based on standard questioners.

·       Primary Outcome: parijata kashaya is effective than snigdha agni karma in gridhrasi vis-a-vis sciatica

·        Secondary Outcome:

1.     snigdha agni karma is effective than parijata kashaya in gridharsi vis-à-vis sciatica.

2.     Both parijata kashaya and snigdha agni karma are combinely effective in gridhrasi vis-à-vis sciatica

·        SUBJECTIVE CRITERIA

·        Radiating pain (Pain in low back and radiating down to back of thigh knee leg and foot)

·         Numbness of affected limb

·        Stiffness

Gradation of subjective criteria

1.     Radiating pain

No radiation pain	G0
Pain radiation to hip and back of thigh	G1
Pain radiation to knee	G2
Pain radiation to foot	G3

 

2.     Numbness of affected limb

No numbness	0
Mild (once in a day)	1
Moderate (2-3times/day)	2
Continuous (whole day & night)	3

 

3.     Jadata(Stiffness)

Mobile Without Pain	0
Mobile with mild Pain	1
Mobile with moderate Pain	2
Fully Stiff	3

·        OBJECTIVE CRITERIA

•      SLR test

•       Bragard’s test

•      Oswestry Low Back Disability Questionnaire

1.     SLR Test or Lasegue’s Test

Negative	0
>60°	1
30° to 60°	2
<30°	3

 

2.     Bragard’s Test

Absent	0
Present	1

 

3.     Oswestry Low Back Disability Questionnaire

 

Study Design

 

Drug Dose and Frequency

·        The Trial Procedure:

§  Name: Snigdha Agni Karma

§  Time of intake: After food

§  Frequency: once daily for 7 days then, once after 1 week for 3 weeks

 

 

 

·        The Control Drug:

§  Name: Parijata Kashaya

§  Dose: 50ml once in divided dose

§  Time of intake: Empty stomach

§  Frequency: Twice daily.

§  The raw materials will be purchased from the market and the drug will be prepared in the GMP certified Rasa shala.

 

Follow up: On 31th & 61th day.

ASSESSMENT

The subjective and objective parameters will be noted during the periodic check-ups. The individual effect of   Parijata Kashaya given orally and Snigda Agni karma will be assessed after observing the patients who completed the treatment duration of 60 days with follow up in every month.

GUIDELINES

·        Guidelines to be covered: All the GCP guidelines will be followed as per recommendation of IEC & SAC, SSCASRH, SSU

·        Project approval: SAC, SSCASRH, SSU and IEC, SSCASRH, SSU

·        Financial Considerations for the Patients: All the Cost of medicines and investigations will be borne by the principal investigator.

STUDY MONITORING AND SUPERVISION

·        Study Monitoring: By observation of improvement on subjective and objective parameters.

·        Study Materials:

o   Case Report Form (CRF)

o   Patient information sheet (PIS), and Patient informed consent (PIC) in the Local Language & National Language.

o   Departmental Research Committee (DRC), IEC clearance

·        Filling of Case Report Forms: Paper or electronic CRFs will be used in the study.

·        Data Handling & Record Keeping:

o   Demographics, Clinical & Laboratory reports, and Drug dispensing data will be considered as source documents.

o   All the data captured in these source documents will be entered into the respective CRFs.

o   All data related to the study will be in the custody of the Investigator.

·        Study management at the site: The study will be managed by the principal investigator and Supervisor

·        Confidentiality:

o   All patient data will be maintained in strict confidentiality.

o   The information will be stored in both soft copy and hard copy format with limited access.

·        Publication: The study outcome will be published in indexed journals.

·        Declaration of Interests:  The investigators declare no conflict of interest.

·        CONCLUSION

Conclusion will be drawn after statistical analysis.