| CTRI Number |
CTRI/2024/10/075479 [Registered on: 17/10/2024] Trial Registered Prospectively |
| Last Modified On: |
11/10/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Ayurvedic management of sciatica by rason saptak qwath. |
|
Scientific Title of Study
|
Randomized controlled clinical trial to evaluate the efficacy of Rasonsaptak kashaya in the management of Gridhrasi (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 Kedar Dandare |
| Designation |
PG Student Kayachikitsa |
| Affiliation |
CSMSS Ayurved Mahavidyalay |
| Address |
CSMSS Ayurved Mahavidyalaya Kanchanwadi Chhatrapati Sambhaji Nagar 431011 CSMSS Ayurved Mahavidyalaya Kanchanwadi Chhatrapati Sambhaji Nagar 431011 Aurangabad MAHARASHTRA 431011 India |
| Phone |
8668331644 |
| Fax |
|
| Email |
kedardandare@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Naresh Nimbalkar |
| Designation |
Associate Professor |
| Affiliation |
Chatrapati Shahu Maharaj Shikshan sanstha Ayurved Mahavidyalaya Kanchanwadi 431011 |
| Address |
OPD Number 13 ,Kayachikitsa Department,CSMSS Ayurved Mahavidyalaya Kanchanwadi Chhatrapati Sambhaji Nagar 431011 OPD Number 13 ,Kayachikitsa Department,CSMSS Ayurved Mahavidyalaya Kanchanwadi Chhatrapati Sambhaji Nagar 431011 Aurangabad MAHARASHTRA 431011 India |
| Phone |
9422711098 |
| Fax |
|
| Email |
ayushakti009@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Naresh Nimbalkar |
| Designation |
Associate Professor |
| Affiliation |
Chatrapati Shahu Maharaj Shikshan sanstha Ayurved Mahavidyalaya Kanchanwadi 431011 |
| Address |
OPD Number13,Kayachikitsa Department,CSMSS Ayurved Mahavidyalaya Kanchanwadi Chhatrapati Sambhaji Nagar 431011 OPD Number13,Kayachikitsa Department,CSMSS Ayurved Mahavidyalaya Kanchanwadi Chhatrapati Sambhaji Nagar 431011 Aurangabad MAHARASHTRA 431011 India |
| Phone |
9422711098 |
| Fax |
|
| Email |
ayushakti009@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dr Kedar Dandare |
| Address |
CSMSS Ayurved Mahavidyalaya Kanchanwadi Chhatrapati Sambhaji Nagar 431011 |
| Type of Sponsor |
Other [SELF sponsered] |
|
|
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 Kedar Dandare |
Chhatrapati Shahu Maharaj Ayurved Mahavidyalay and Hospital |
OPD Number 13 Department of Kayachikitsa CSMSS Ayurved Mahavidyalaya Kanchanwadi 431011 Aurangabad MAHARASHTRA |
8668331644
kedardandare@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| CSMSS Ayurveda mahavidayalaya va rugnalaya Kanchanwadi Aurangabad 431011 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:M958||Other specified acquired deformities of musculoskeletal system. Ayurveda Condition: GRUDHRASI, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Shefali patra kwath, Reference: Bhavprakash Madhyam Khanda Vat vyadhi 26-142, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 40(ml), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: -Koshna Jala), Additional Information: - | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Rason Saptak Kashay, Reference: Bharat bhaishajyaratnavali 4th part vatvyadhi shloka number 5860, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 40(ml), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: Eranda Kwath), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
-Patients showing Classical Lakshana of Gridhrasi(Sciatica) in working population.
- Patients having positive SLR Test on examination.
- Patients irrespective of both genders will be selected
|
|
| ExclusionCriteria |
| Details |
-The patients suffering from following conditions will be excluded from the study Disease of spine: Like Osteoarthritis Of spine, Spondylolisthesis, Ankylosing spondylitis, Rheumatoid arthritis of hip joint.
- Tuberculosis of vertebral column
|
|
|
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
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
RUKA (Pain), TODA (Pricking sensation),STAMBHA (Stiffness),SPANDANA (Twitching),Gaurava (Heaviness) will reduce.
|
10th,20th,30th day
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Straight Leg Raising Test-With the help of Goniometer will asses grades and grade will reduce further treatment |
10th,20th,30th day |
|
|
Target Sample Size
|
Total Sample Size="92" Sample Size from India="92"
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 2/ Phase 3 |
|
Date of First Enrollment (India)
|
25/10/2024 |
| 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="6" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
The sign and symptoms of sciatica found in modern medicine are quietly mimic with the condition of gridhrasi mentioned in ayurveda.vatavyadhi (vata disorder) is one of the most common health issue people suffer from, and almost every person suffers in his lifetimes. “Gridhrasi" is one among the 80 diseases of vata under the nanatmaj vyadhi . Person suffers from grievous pain due which he walks in particular style and so this disease is named as gridhrasi. While walking the patient slightly leans towards the affected side with the affected leg in flexed position and other leg extended position. Gridhrasi, the name itself indicates the way of Gait shown by the patient due to extreme pain that is "gridha†or vulture.According to charaka acharya, gridhrasi is caused by “aggravated vata†affecting the hip first, which is afflicted by stiffness (stambha), pricking(toda) sensation and pain (ruka) which further radiates towards the waist, back, thigh, knee and calf region in order. These regions constantly have twitching sensation(muhuspanda) .The rasonsaptak Kashaya is advised in bharat bhaishajya ratnavali which is vata and kapha shamak which is used in kwath for which may produce potent and deeper
action against gridhrasi. Therefore study is undertaken to evaluate the effect
of rasonsaptak kashaya in management of gridhrasi. |