| CTRI Number |
CTRI/2024/11/077206 [Registered on: 21/11/2024] Trial Registered Prospectively |
| Last Modified On: |
13/11/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
To study the effect of Viddhakarma and additional effect of Rasnadi gudika with Viddhakarma in Gridhrasi(sciatica) |
|
Scientific Title of Study
|
A Randomized Controlled Clinical Study to evaluate the add on effect of Rasnadi gudika with Viddhakarma in the management of Gridhrasi |
| 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 Ankita Rajkumar Maurya |
| Designation |
PG Scholar |
| Affiliation |
PDEAs College of Ayurved and Research Centre,Pune |
| Address |
PDEAs College of Ayurved and Research Centre,Third
floor,Shalyatantra department Sector no.25,Nigdi Pradhikaran
Pune
MAHARASHTRA
411044
India |
| Phone |
8425927033 |
| Fax |
|
| Email |
ankitarmaurya@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Kiran Mendhekar |
| Designation |
Associate Professor |
| Affiliation |
PDEAs College of Ayurved and Research Centre,Pune |
| Address |
PDEAs College of Ayurved and Research Centre,Third
floor,Shalyatantra department Sector no.25,Nigdi Pradhikaran
Pune
MAHARASHTRA
411044
India |
| Phone |
9867802319 |
| Fax |
|
| Email |
doctor.kiran.mendhekar@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Kiran Mendhekar |
| Designation |
Associate Professor |
| Affiliation |
PDEAs College of Ayurved and Research Centre,Pune |
| Address |
PDEAs College of Ayurved and Research Centre,Third
floor,Shalyatantra department Sector no.25,Nigdi Pradhikaran
Pune
MAHARASHTRA
411044
India |
| Phone |
9867802319 |
| Fax |
|
| Email |
doctor.kiran.mendhekar@gmail.com |
|
|
Source of Monetary or Material Support
|
| PDEAs College of Ayurved and Research Centre,Nigadi,Pune Maharastra 411044 India |
|
|
Primary Sponsor
|
| Name |
PDEAs College of Ayurved and Research Centre,Nigadi,Pune |
| Address |
PDEAs College of Ayurved and Research Centre,Third
floor,Shalyatantra department Sector no.25,Nigdi Pradhikaran,Pune
MAHARASHTRA |
| Type of Sponsor |
Private medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Ankita Rajkumar Maurya |
Ayurved Rugnalya and Sterling Multi-speciality Hospital,Nigadi,Pune. |
Shalyatantra
Department, OPD No
123A Pradhikaran Nigdi
Pune
MAHARASHTRA |
08425927033
ankitarmaurya@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Instituitional Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:G55||Nerve root and plexus compressionsin diseases classified elsewhere. Ayurveda Condition: GRUDHRASI, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | Viddhakarma | (Procedure Reference: Sushruta Sutrasthana Adhyay- 5, Procedure details: Patient will be asked to lie down on bed in right/left lateral position according to the affected leg.
Points will be marked 4 finger above & 4 finger below the knee joint on lateral aspect of affected leg with the help of skin marker.
Under all aseptic precautions by using disposable gauge needle no. 26, marked points will be pierced at 45 degrees angle up to depth 3- 4 mm.
The needle will be placed in the same position for 30sec.
The needle used will be discarded in white puncture proof container once used.)
(1) Medicine Name: Rasnadi Gudika , Reference: Chakradutta, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/Tablets, Dose: 500(mg), Frequency: bd, Duration: 21 Days | | 2 | Comparator Arm | Procedure | - | Viddhakarma | (Procedure Reference: Sushruta Sutrasthana Adhyay-5, Procedure details: Patient will be asked to lie down on bed in right/left lateral position according to the affected leg.
Points will be marked 4 finger above & 4 finger below the knee joint on lateral aspect of affected leg with the help of skin marker.
Under all aseptic precautions by using disposable gauge needle no. 26, marked points will be pierced at 45 degrees angle up to depth 3- 4 mm.
The needle will be placed in the same position for 30sec.
The needle used will be discarded in white puncture proof container once used.)
|
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patient with clinical features of Gridhrasi that is Ruka (Pain), Toda (Pricking Pain), Stambha (stiffness), Suptata (Numbness), in Sphik, Kati, Uru, Janu, Jangha and Pada.
Irrespective of Religion, Caste, Gender and Socioeconomic status.
|
|
| ExclusionCriteria |
| Details |
Pregnant women.
Known case of Uncontrolled diabetes mellitus, diabetic neuropathies and Accelerated hypertension.
Known case of Tuberculosis, Malignancy of spine and hip joint.
Major Trauma, Fracture and tumor related to spine, hip bone and femur. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
A clinical study to access the effect of viddhakarma
and add on effect of Rasnadi gudika with Viddhakarma
in reducing tod (pricking pain) sthambha
(stiffness) spandan (throbbing) in gridhrasi
(sciatica) |
patient asssessment will be done on 7th,14 th & 21st day |
|
|
Secondary Outcome
|
|
|
Target Sample Size
|
Total Sample Size="66"
Sample Size from India="66"
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)
|
01/12/2024 |
| 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="0"
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
|
Basically,ayurveda is mainly based on the concept of Tridosha i.e. Vata,Pitta,Kapha among this all Vata is the main dosha. All the Vata vyadhi described in Samhita throughly, in that all vata vyadhi. Gridhasi is one of the Vata vyadhi which have symptoms mailnly mentioned as- Pain start from sphik pradesh and radiating downwards to kati pradesh and it continuous to prushta pradesh, uru pradesh, Janu pradesh,Jangha pradesh. In Gridhasi patient is unable to walk properly. This is similar to Sciatica in modern science by its signs and symptoms. Symptomatically in which pain begins in lumbar region and radiates posterio-lateral aspects of thigh and one or Bilateral lower limb,for this Viddhakarma is performed it will give instant relief from pain and other symptoms without any side effects. |