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CTRI Number  CTRI/2025/03/081650 [Registered on: 05/03/2025] Trial Registered Prospectively
Last Modified On: 05/03/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   To see the effect of Simhasyadi Kwath and Gridhrasinashak Kwath and compare their action in the treatment of Gridhrasi with reference to Sciatica 
Scientific Title of Study   A RANDOMIZED CLINICAL STUDY TO COMPARE THE EFFICACY OF SIMHASYADI KWATH AND GRIDHRASINASHAK KWATH IN THE MANAGEMENT OF GRIDHRASI W.S.R. TO SCIATICA  
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Ashwini Gajananrao Jichkar 
Designation  MD Kayachikitsa Scholar (Ayurved) 
Affiliation  Dr. VJD Gramin Ayurved Mahavidyalaya ,Patur, Akola 
Address  Dr.VJD Gramin Ayurved Mahavidyalaya OPD No 3 Department of Kayachikitsa, Near Renuka mata mandir, Patur,Tq. Patur Dist. Akola Pin 444501 MAHARASHTRA INDIA
Dr.VJD Gramin Ayurved Mahavidyalaya, OPD No 3 Department of Kayachikitsa, Near Renuka mata mandir, Patur,Tq. Patur Dist. Akola Pin 444501 MAHARASHTRA INDIA
Akola
MAHARASHTRA
444501
India 
Phone  9075169866  
Fax    
Email  ashwinijichkar09@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Ashish Keche 
Designation  Associate Professor 
Affiliation  DR VJD Gramin Ayurved Mahavidyalaya,Patur 
Address  DR VJD Gramin Ayurved Mahavidyalay OPD No 3 Department of Kayachikitsa Near Renuka mata mandir, Patur,Tq. Patur Dist. Akola Pin 444501 MAHARASHTRA INDIA
DR VJD Gramin Ayurved Mahavidyalay OPD No 3 Department of Kayachikitsa Near Renuka mata mandir, Patur,Tq. Patur Dist. Akola Pin 444501 MAHARASHTRA INDIA
Akola
MAHARASHTRA
444501
India 
Phone  8149921892  
Fax    
Email  rajeashish09@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Ashish Keche 
Designation  Associate Professor 
Affiliation  DR VJD Gramin Ayurved Mahavidyalaya,Patur 
Address  DR VJD Gramin Ayurved Mahavidyalay OPD No 3 Department of Kayachikitsa, Near Renuka mata mandir, Patur,Tq. Patur Dist. Akola Pin 444501 MAHARASHTRA INDIA
DR VJD Gramin Ayurved Mahavidyalaya OPD No 3 Department of Kayachikitsa,Near Renuka mata mandir ,Patur,Tq. Patur Dist. Akola Pin 444501 MAHARASHTRA INDIA
Akola
MAHARASHTRA
444501
India 
Phone  8149921892  
Fax    
Email  rajeashish09@gmail.com  
 
Source of Monetary or Material Support  
Dr VJD Gramin Ayurved Mahavidyalaya Patur Tq Patur Dist Akola Maharashtra India Pin 444501 
 
Primary Sponsor  
Name  Dr. VJD Gramin Ayurved Mahavidyala 
Address  Dr. VJD Gramin Ayurved Mahavidyala,near Renuka Mata Mandir Patur Tq Patur Dist Akola Pin 444501 Maharashtra INDIA 
Type of Sponsor  Research institution and hospital 
 
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 Ashwini Gajananrao Jichkar   Dr VJD Gramin Ayurveda Mahavidyalaya and Hospital and Research center   OPD No 3 Department of Kyachikitsa Dr VJD Gramin Ayurveda Mahavidyalaya, near Renuka Mata mandir, Patur, Tal Patur,Dist Akola
Akola
MAHARASHTRA 
9075169866

ashwinijichkar09@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics committee Dr VJD Gramin Ayurved Mahavidyalaya ,Patur, Akola  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  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Comparator ArmDrugClassical(1) Medicine Name: Gridhrasinashak Kwath , Reference: Sharangdhar samhita Dwitiya khanda 2/85, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 30(ml), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 45 Days, anupAna/sahapAna: Yes(details: koshnajal ), Additional Information: -
2Intervention ArmDrugClassical(1) Medicine Name: SIMHASYADI KWATH , Reference: Bhavprakash madhyam khanda Vatavyadhi 140, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 30(ml), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 45 Days, anupAna/sahapAna: Yes(details: Koshnajal), Additional Information: -
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1.Patients showing classical symptoms and sign of Gridharsi described in ayurvedic samhitas.
2.Radiating pain along the course and distribution of sciatic nerve that is in buttock to outer border of foot.
3.SLR Test of patient – positive up to 60 degree. 4. Lasegue’s sign positive.
5.Patients between the age of 20-60 years.
6.Patients from all socio-economic status.
7. Either sex.
 
 
ExclusionCriteria 
Details  1.Patients not willing.
2.Pregnant and lactating mothers.
3.Infective disorders – T.B. of spine, osteomyelitis, etc.
4.Patients with paraplegia of lower limb.
5.Fracture of spinal bones or in lower extremity bones.
6.Patients having congenital anomalies with lumbosacral spine such as kyphosis, scoliosis.
7.Patients having any major chronic/acute; systemic/surgical Pathology.
8.Patients with deep wounds penetrating till sciatic nerve.
9.Diabetes Mellitus.
10.Patient below 20 yrs age and above 60 yrs age.

 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Symptoms like 1)Sphikpurva kati, Uru, Janu, Jangha ,pada Kramat ruja (Pain).
2)Stambha (Stiffness)
3)Toda (Pricking sensation/Tingling)
4)Spandan (Twitching)
5)Gaurav (Feeling of Heaviness)
6)Aruchi.
 
15 days,30 days and 45 days after starting treatment. 
 
Secondary Outcome  
Outcome  TimePoints 
Decrease in overall symptoms   18 months 
 
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   N/A 
Date of First Enrollment (India)   17/03/2025 
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="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  

Gridhrasi is one of the Nanatmaja Vata Vyadhi caused by Vitiation of vayu. The name Gridhrasi is derived From the word "Grudhra" that literally means a "vulture".

           The Patient suffering From this disease walks like a vulture(Grudhra) due to severe, persistant & migrating pain, so the name of this disease or vyadhi is"Gridhrasi". If the patient right leg is affected by Gridhrasi Vyadhi patient bears all his weight on his left leg & vice versa. This typical gait looks like that of Grudhra’s (vulture’s) walk hence this disease is called Gridhrasi. These Symptoms are similar to the symptoms of "sciatica" described in modern medical science. The Pratyatma Lakshana of Gridhrasi is migrating pain from Sphika (hip), Kati(waist). Prushta(back), uru(groin), Janu(knee) & Jangha(thigh) to pada(foot). Classical pain of Gridhrasi is accompanied by Stambha(rigidity), Ruja(pain), Tod (Pricking pain) & the patient feels recurrent through along affected leg.

          The objective of this cross-sectional study was to estimate the 6 month Prevalence and severity of low back pain & sciatica in a representative sample of 674 adults aged 20 years or older from a mainly (74.8%) urban population. Information regarding low back pain & sciatica prevalence & severity & its related aspects, as well as socioeconomic & demographic characteristics was collected by personaI interviews with a validated questionnaire. A total of 266(39.5%) patients reported low back pain &166(24.68) reported sciatica during the previous 6 month period.

                      The lifetime Prevalence of a low back pain is reported to be more than 70% in industrialized countries. 1 year prevalence 15% to 45% adult incidence 5% per year with varying degrees of symptom severity.

          The prevalence of low back pain during school age approaches that seen in adult. Increases from childhood to adolescence and peaks between age 35 & 55 years.

Gridhrasi is one among the 80 types of Vataj Nanathmaja Vyadhis. The chances of Gridhrasi is expected to increase in the upcoming years due to sedentary life style, the increased used of computerization & also due to increasing body weight, mental stress hectic work schedules & excessive travelling.

         All these adds on to the improper posture which is one of the highlighted cause for spine & nerve compression disorder in the present scenario.

       Low back pain is the 2nd most common reason for all physician visits & it is condition that affects as many as 80-90% of people during their life time, among them true sciatica causes occurs in about 5% cases. On considering sciatica as an independent disease it is relatively common condition with life time incidence varying from 1.6% -43%. Sciatica is more common among the age group between 20-60-years of age.

      It is a fact that despite recent progress of modern neurology. It is unable to provide an effective cure for sciatica, except for giving temporary relief through analgesic or surgical interventions continuous use of NSAIDS and steroids for reliving pain may in later course. Lead to secondary complication like kidney failure, liver disorder & gastritis.

             Keeping these facts in mind this study has been under taken to bring out a treatment modality with no side effects & long lasting relief.

           In this study the role of Hingwadi Kwath & Shefali Patra Kwath which is simple & potent yoga described in Sharangdhar Samhitas and Bhaishajya Ratnavali with specified indication only on Gridhrasi.

 

 
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