| CTRI Number |
CTRI/2024/07/071074 [Registered on: 23/07/2024] Trial Registered Prospectively |
| Last Modified On: |
11/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Other (Specify) |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Ayurvedic Treatment for sciatica |
|
Scientific Title of Study
|
A Comparative Clinical Study to Evaluate the Efficacy of Ashtakatvarataila with Gokshuraditaila Matrabasti and Dashamulakashaya as Shamanoushadhi in Gridhrasi vis- a -vis 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 Sangeetha N |
| Designation |
PG Scholar |
| Affiliation |
Government Ayurveda Medical College ,Mysuru |
| Address |
Post Graduate Department of Kayachikitsa Government Ayurveda Medical College and Hospital Mysuru Vishweshwaraiah circle Devraja Mohalla Mysuru Karnataka 570001 India
Mysore
KARNATAKA
570001
India |
| Phone |
8722240385 |
| Fax |
|
| Email |
sangeethashetty9298@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DrMythrey RC |
| Designation |
Professor and Head of the Department |
| Affiliation |
Government Ayurveda Medical College,Mysuru |
| Address |
Post Graduate Department of Kayachikitsa Government Ayurveda Medical College and Hospital Mysuru Vishweshwaraiah circle Devraja Mohalla Mysuru Karnataka 570001 India
Mysore
KARNATAKA
570001
India |
| Phone |
8618570803 |
| Fax |
|
| Email |
mythreyrc@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DrSangeetha N |
| Designation |
PG Scholar |
| Affiliation |
Government Ayurveda Medical College Mysuru |
| Address |
Post Graduate Department of Kayachikitsa Government Ayurveda Medical College and Hospital Mysuru Vishweshwaraiah circle Devraja Mohalla Mysuru Karnataka 570001 India
Mysore
KARNATAKA
570001
India |
| Phone |
8722240385 |
| Fax |
|
| Email |
sangeethashetty9298@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government Ayurveda Medical College and Hospital Mysuru Karnataka India 570001 |
|
|
Primary Sponsor
|
| Name |
Dr Sangeetha N |
| Address |
Department of Post Graduate
Studies in Kayachikitsa Government Ayurveda Medical College Mysuru karnataka 570001 India |
| Type of Sponsor |
Other [Self ] |
|
|
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 Sangeetha N |
Government Ayurveda Medical College and Hospital |
Room No 10 kayachikitsa OPD Ground floor Vishwesharaiah circle Devaraja Mohalla 570001 Mysuru Karnataka
Mysore
KARNATAKA |
8722240385
sangeethashetty9298@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Government Ayurveda Medical College and Hospital Mysuru |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:M511||Thoracic, thoracolumbar and lumbosacral intervertebral disc disorders with radiculopathy. Ayurveda Condition: GRUDHRASI, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Ashtakatvara taila, Reference: charaka samhita chikitsa stana urustambha chikitsa adhyaya, Route: Rectal, Dosage Form: Taila, Dose: 72(ml), Frequency: od, Bhaishajya Kal: Adhobhakta, Duration: 8 Days, anupAna/sahapAna: No, Additional Information: -(2) Medicine Name: Gokshuradi taila, Reference: vangasena samhita vatavyadhi adhikara, Route: Rectal, Dosage Form: Taila, Dose: 72(ml), Frequency: od, Bhaishajya Kal: Adhobhakta, Duration: 8 Days, anupAna/sahapAna: No, Additional Information: - | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Dashamula kashaya, Reference: sharangadhara samhita kashaya prakarana, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 24(ml), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 30 Days, anupAna/sahapAna: No, Additional Information: -prakshepaka of hingu and pushkaramula churna will be used |
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Subjects with signs and symptoms of Gridhrasi vis-Ã -vis Sciatica between the age group of 20-60 irrespective of gender, religion, socio-economic status, occupation will be selected for the study. Both freshly detected and treated cases of Gridhrasi vis-Ã -vis Sciatica (with the flush out
period of seven days) will be taken for the study. A. Fresh cases include freshly detected and untreated cases of Gridhrasi vis-a-vis Sciatica will be included.
B. Treated cases include already diagnosed as Gridhrasi vis-Ã -vis Sciatica, who had voluntarily discontinued the treatment with the flush out period of 7 days.
|
|
| ExclusionCriteria |
| Details |
Subjects with history of recent fracture (less than 1 year) of lumbar spine will be excluded. Subjects who are unfit for administration of Matra basti will be excluded.
Pregnant and lactating women will be excluded.
Subjects suffering from Diabetes mellitus (RBS above 250mg/dl), uncontrolled hypertension
(above 160/100 mm Hg) and other systemic disorders which will interfere with the intervention will be excluded.
Neoplastic/Infective/congenital conditions of the lumbar spine will be excluded. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Assessing the efficacy between Ashtakatvara and Gokshuradi Taila matrabasti and Dashamulakashaya orally in relieving symptoms of sciatica like Radiating pain,stiffness |
at baseline,9th day(mid assessment), 39th day(post assessment) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To evaluate the efficacy of Ashtakatvara and Gokshuradi Taila matra basti followed by Dashamula Kashaya orally in reliving symptoms of sciatica like radiating pain,stiffness |
second assessment 9th day and third assessment 39th day |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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)
|
01/08/2024 |
| 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
|
Gridhrasi is ruja pradhana vataja nanatmaja vyadhi.The cardinal signs and symptoms of Gridhrasi are pain in chronological order from sphik, kati, prushta, uru, janu, jangha and pada stambha and muhurspandana and sakthikshepa nigraha Tandra gourava and arochaka are the symptoms present in kaphanubandha gridhrasi . The signs and symptoms of Gridhrasi is compared to Sciatica. It is defined as radiating pain along the course of sciatic nerve and is felt in the back,buttocks,posterior thigh,legs and foot. The lifetime incidence is reported between 10%to 40%,annual incidence of 1-5% and peak incidence occurs in in patient in their fourth decade. Occupational predisposition has been shown in machine operators, truck drivers and the workers who are subjected to physically awkward positions pertaining to their jobs. Management of sciatica in contemporary science involves oral NSAID’S, muscle relaxants, oral cortico- steroids, lumbar traction, intravertebral steroid injection and surgery. Management of pain is the first choice in sciatica for which NSAID’s are widely used. Long term usage of NSAID’s leads to gastric pain, mucosal erosion/ulceration and blood loss are produced to varying extents. Procedures like intravertebral steroid injection and surgery are not economical to majority of the population. Hence an approach which is effective, simple and affordable is required. In Ayurvedic classics management of Gridhrasi includes basti karma, siravyadha,agnikarma. Basti is considered to be Hita Chikitsa in diseases caused due to vata,pitta,kapha,rakta, samsarga and sannipata doshas Ashtakatvara and Gokshuradi taila are having specific indication for Gridhrasi . Dashamula Kashaya is having Tridoshagna, vedanastapaka and shothagna properties. Hence in the present study, matra basti with Ashtakatvara taila and Gokshuradi taila followed by Dashamula Kashaya orally is taken for comparative evaluation of the possible effect on Gridhrasi . |