CTRI

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CTRI Number

CTRI/2023/06/053405 [Registered on: 01/06/2023] Trial Registered Prospectively

Last Modified On:

01/06/2023

Post Graduate Thesis

Yes

Type of Trial

Interventional

Type of Study

Drug
Ayurveda

Study Design

Randomized, Parallel Group Trial

Public Title of Study

Clinical study of Meshashrungyadi kashaya and Rasna guggul in the management of Gridhrasi w.s.r. to Sciatica Neuritis.

Scientific Title of Study

Comparative clinical study of Meshashrungyadi kashaya and Rasna guggul in the management of Gridhrasi w.s.r. to Sciatica Neuritis.

Trial Acronym

Secondary IDs if Any

Secondary ID	Identifier
NIL	NIL

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

Name	Dr Manohar Lal Menariya
Designation	PG Scholar
Affiliation	Shubhdeep Ayurved Medical College and Hospital Indore
Address	G 10, Department of kayachikitsa Shubhdeep Ayurved Medical College and Hospital Indore Indore MADHYA PRADESH 452020 India
Phone	9993105714
Fax
Email	drmmenariya@gmail.com

Details of Contact Person
Scientific Query

Name	Dr Deepak Sohgoura
Designation	Professor
Affiliation	Shubhdeep Ayurved Medical College and Hospital Indore
Address	F22, Shubhdeep Ayurved Medical College and Hospital Indore Indore MADHYA PRADESH 452020 India
Phone	8979087079
Fax
Email	drdeepaktiwari3.ds@gmail.com

Details of Contact Person
Public Query

Name	Dr Umesh Patil
Designation	Associate Professor
Affiliation	Shubhdeep Ayurved Medical College and Hospital Indore
Address	G42, Shubhdeep Ayurved Medical College and Hospital Indore Indore MADHYA PRADESH 452020 India
Phone	9826052986
Fax
Email	umeshpatil0704@gmail.com

Source of Monetary or Material Support

Shubhdeep Ayurved Medical College Indore

Primary Sponsor

Name	Shubhdeep Ayurved Medical College and Hospital Indore
Address	Shubhdeep Ayurved Medical College and Hospital Village Datoda Khandwa Road Indore 452020
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
DR MANOHAR LAL MENARIYA	SHUBHDEEP AYURVED MEDICAL COLLEGE AND HOSPITALINDORE	Room No. 10, Kayachikitsa Department, SAMCH, GRAM DATODA KHANDWA ROAD INDORE Indore MADHYA PRADESH	9993105714 drmmenariya@gmail.com

Details of Ethics Committee

No of Ethics Committees= 1
Name of Committee	Approval Status
INSTITUTIONAL ETHICAL COMMITTEE	Approved

Regulatory Clearance Status from DCGI

Status

Not Applicable

Health Condition / Problems Studied

Health Type	Condition
Patients	(1) ICD-10 Condition:M543\|\|Sciatica. Ayurveda Condition: GRUDHRASI,

Intervention / Comparator Agent

sno	Intervention/Comparator	Type	Drug-Type	Procedure Name	Details
1	Intervention Arm	Drug	Classical		(1) Medicine Name: Meshashrungyadi Kashaya, Reference: Vangsen Samhita, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 40(ml), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 45 Days, anupAna/sahapAna: No, Additional Information: - (2) Medicine Name: Rasna Guggul, Reference: Bhaisajya Ratnavali, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 45 Days, anupAna/sahapAna: Yes(details: -Lukewarm Water), Additional Information: -
2	Comparator Arm	Drug	Classical		(1) Medicine Name: Meshashrungyadi Kashaya, Reference: Vangsen Samhita, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 40(ml), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 45 Days, anupAna/sahapAna: No, Additional Information: -
3	Comparator Arm	Drug	Classical		(1) Medicine Name: Rasna Guggul, Reference: Bhaisajya Ratnavali, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 45 Days, anupAna/sahapAna: Yes(details: -LUKEWARM WATER), Additional Information: -

Inclusion Criteria

Age From	20.00 Year(s)
Age To	60.00 Year(s)
Gender	Both
Details	1. Patients with clinical signs and symptoms of Gridhrasi with back pain radiating to thigh foot will be selected. 2.Patients of either gender with the age group between 20-60 years will be selected. 3. Patients with Positive SLRT are selected. 4.Patients willing to participate in this study and after given their concent.

ExclusionCriteria

Details

1. Patient not fulfilling the inclusion criteria.
2. Age below 20 years and above 60 years.
3. Patients suffering from the following diseases will be excluded from the study- Spinal Deformity ,Spinal Tumors, Spinal TB, Severe Traumatic Injury, Viral Infection like Poliomyelitis, Carcinoma of the Spine, Congenital abnormalities in spine,Surgical indication.

Method of Generating Random Sequence

Random Number Table

Method of Concealment

Case Record Numbers

Blinding/Masking

Open Label

Primary Outcome

Outcome	TimePoints
No pain No pricking sensation No stiffness No Twitching Equally willing towards all food Normal mental and physical alertness No heaviness	45 Days

Secondary Outcome

Outcome	TimePoints
NA	NA

Target Sample Size

Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials"

Phase of Trial

Phase 3

Date of First Enrollment (India)

10/06/2023

Date of Study Completion (India)

Applicable only for Completed/Terminated trials

Date of First Enrollment (Global)

Date Missing

Date of Study Completion (Global)

Applicable only for Completed/Terminated trials

Estimated Duration of Trial

Years="3"
Months="0"
Days="0"

Recruitment Status of Trial (Global)

Not Applicable

Recruitment Status of Trial (India)

Not Yet Recruiting

Publication Details

NIL

Individual Participant Data (IPD) Sharing Statement

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

Response - NO

Brief Summary

In Ayurveda , various modalities of treatment are explained for the management of Gridhrasi. For a person, to be healthy he should be mentally and spiritually happy. So there is need for safe and effective treatment. Gridhrasi is given as a Vatavyadhi and it is also believed that any type of Pain can not be without presence of Vata. Gridhrasi is a severely painful condition so, Vata Pradhanya in its pathogenesis is clear. In Ayurvedic classics taxts, our Acharyas have given so many special therapeutical procedures for specific disease along with thousands of medicines.

Meshashrungyadi Kashaya And Rasna guggul both are effective medicine for Gridhrasi because of its Preventive, Promotive, Prophylactic and Rejuvinative properties as well as providing a radial cure . These two medicine is applicable in all the VatavyadhI. The disease Gridhrasi as being a Vatavyadhi and Vata is also controller and regulator of other two Dosha , Dhatu and Mala and also all the body activities. Therefore, once Vata is controlled by Meshashrungyadi And Rasna guggul is also work on Vata-Kaphaja doshas and Aam pachak . Mainly Meshashrungyadi kashaya is good for Srotorodhajanya Vatavyadhi and Rasna Guggul is for Vatavyadhy.

It is evident that Meshashrungyadi kashaya is well known and proven that it works for all type of Vatavyadhyâ€™s as Vata shamak chikitsa or Neuro-muscular diseases. Rasna Guggul is works as Kapha-Pitta shamak dosh karmata and also works as Rasyana. So after the combination of both the medicines works as Vata pradhan Tridosh shamak.

There are 3 comparative groups in my study to diffrentiate and evaluate the efficacy of individual group and combined group for study 60 Patients of OPD/ IPD of SAMC have been selected irrespective of gender, religion and occupation.

Hence I have selects this drugs singly and combined comparatively study to evaluate its efficacy or manage in Gridhrasi( Sciatica) in a well manners. Hence I have taken this two medicine Meshashrungyadi kashaya And Rasna guggul to evaluate its effect in the Gridhrasi (Sciatica Neuritis)