| CTRI Number |
CTRI/2024/10/075581 [Registered on: 21/10/2024] Trial Registered Prospectively |
| Last Modified On: |
07/10/2024 |
| 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
|
Compare effect of Saindhavadi oil and Vajigandhadi oil administered Per rectal route in treatment of Sciatica. |
|
Scientific Title of Study
|
A clinical comparative study of efficacy of Saindhavadi Taila and Vajigandhadi Taila Matrabasti 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 |
Govinddev Rajendra Jhirmiria |
| Designation |
post graduate resident |
| Affiliation |
APMs Ayurved Mahavidyalaya sion |
| Address |
Department of Panchkarma 2nd floor, APMs Ayurved Mahavidyalaya sion, near sion railway station, Sion East, Mumbai 400022.
Mumbai
MAHARASHTRA
400022
India |
| Phone |
08080717752 |
| Fax |
|
| Email |
gomzhir@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vishwajeet Jayavant Patade |
| Designation |
professor |
| Affiliation |
APMs Ayurved mahavidyalaya sion |
| Address |
Department of Panchkarma, 2nd floor, APMs Ayurved Mahavidyalaya sion, near sion railway station, Sion East, Mumbai 400022.
Mumbai
MAHARASHTRA
400022
India |
| Phone |
08080717752 |
| Fax |
|
| Email |
drvishup@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Vishwajeet Jayavant Patade |
| Designation |
professor |
| Affiliation |
APMs Ayurved mahavidyalaya sion |
| Address |
Department of Panchkarma 2nd floor, APMs Ayurved Mahavidyalaya sion, near sion railway station, Sion East Mumbai 400022
Mumbai
MAHARASHTRA
400022
India |
| Phone |
08080717752 |
| Fax |
|
| Email |
drvishup@gmail.com |
|
|
Source of Monetary or Material Support
|
| Ayurvidya Prasarak Mandal,
Ground floor, Ayurved Mahavidyalaya near sion railway station, Sion East, Mumbai 400022, Maharashtra. |
|
|
Primary Sponsor
|
| Name |
Govinddev Rajendra Jhirmiria |
| Address |
APMs Ayurved Mahavidyalaya sion near sion railway station Mumbai 400022 |
| 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 Govinddev Rajendra Jhirmiria |
APMs Ayurved Mahavidyalaya and Seth RV Ayurved Hospital |
Department of Panchakarma,Hospital Building, near Dhanvantari temple, ground flooor, APMs Ayurved Mahavidyalaya, near sion railway station, sion east, Mumbai 400022
Mumbai
MAHARASHTRA |
8080717752
gomzhir@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| APMs Ayurved Mahavidyalaya sion IEC |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:M543||Sciatica. Ayurveda Condition: GRUDHRASI, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Vajigandhadi Taila, Reference: Vangasen Samhita, Chapter 60, Shlok 607, Route: Rectal, Dosage Form: Taila, Dose: 60(ml), Frequency: od, Bhaishajya Kal: Adhobhakta, Duration: 14 Days, anupAna/sahapAna: No, Additional Information: MATRA BASTI | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Saindhavadi Taila, Reference: Vangasen Samhita , Chapter 60, Shlok 610-611, Route: Rectal, Dosage Form: Taila, Dose: 60(ml), Frequency: od, Bhaishajya Kal: Adhobhakta, Duration: 14 Days, anupAna/sahapAna: No, Additional Information: MATRA BASTI |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
AGE- 18-70 years
SEX- Both genders
Patient having pratyatma lakshana of Gridhrasi.
Shooting pain radiating from sphika (gluteal region) to pada (foot).
Ruka (pain)
Toda (pricking sensation)
Stambha (stiffness)
Spandana (twitching)
Patient having positive SLR test on clinical examination.
Patient willing to participate in trial. |
|
| ExclusionCriteria |
| Details |
In secondary Complication- Tuberculosis of the vertebral column.
Spinal deformity, spinal tumors, severe traumatic injury, Carcinoma of spine
Patient of Gridhrasi involving any structural deformities and needs surgical
care/intervention will be excluded.
Pregnant women and lactating mothers.
Uncontrolled diabetes mellitus, cardiovascular disease |
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Straight Leg Raise test
Visual Analogue Scale (VAS) |
14 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Ruk / Shoola (pain)
Toda (pricking sensation)
Stambha (stiffness)
Spandana (twitching) |
14 days |
|
|
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
|
Phase 4 |
|
Date of First Enrollment (India)
|
01/11/2024 |
| 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
|
As per Harvard Health Publishing, Sciatica is one of the most common, yet misunderstood, types of pain. As many as 40% of people will get it during their life, and it becomes more frequent as you age. Sciatica does not need to be a pain to treat. There are several ways to minimize and manage flare-ups. As far as treatment of sciatica is concerned, allopathy management such as use of analgesics, muscle relaxant, physical exercise and physiotherapy such as TENS, SWD etc. will help to certain extent but is not the ultimate cure. Likewise, Surgeries are expensive and also there are chances of recurrence or there may be other complications post surgery. Ayurveda offers ample of better options in long term management of this painful disorder and improving the quality of life. Randomised Clinical trial will be conducted on a sample size of 60 patients from OPD and IPD at institutional level. Patients diagnosed with Gridhrasi will be divided in 2 groups of 30 each. Matra Basti of Trial and Comparative drug will be administered to both group respectively for 14 days and will be evaluated for the changes in the symptoms in both groups on daily basis. Data would be analyzed on the basis of data collected by applying appropriate statistical tools. |