| 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 |
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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 |
|
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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 |
|
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Details of Secondary Sponsor
|
|
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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 |
|
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Regulatory Clearance Status from DCGI
|
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:M543||Sciatica. Ayurveda Condition: GRUDHRASI, |
|
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Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Drug | Classical | | (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: - | | 2 | Intervention Arm | Drug | Classical | | (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: - |
|
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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.
|
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Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
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Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
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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. |
|
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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 |
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Publication Details
|
N/A |
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Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
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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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