| CTRI Number |
CTRI/2018/03/012346 [Registered on: 06/03/2018] Trial Registered Prospectively |
| Last Modified On: |
23/09/2020 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Effect of Vaitarana Basti and Rasna Guggulu in Sciatica |
|
Scientific Title of Study
|
Assessment Of Vaitarana Basti And Rasna Guggulu In The Management Of Pain In Gridhrasi (Sciatica) A Randomized Controlled Clinico Experimental Study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Praveen Kumar K S |
| Designation |
PhD Scholar |
| Affiliation |
IPGT and RA Jamnagar |
| Address |
Department of Panchakarma
IPGT and RA
Gujarat Ayurved University
Jamnagar
Gujarat
Jamnagar
GUJARAT
361008
India |
| Phone |
9447506528 |
| Fax |
|
| Email |
drpraveenkumarks@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof Anup Thakar |
| Designation |
Director IPGT and RA |
| Affiliation |
IPGT and RA Jamnagar |
| Address |
Department of Panchakarma
IPGT and RA
Gujarat Ayurved University
Jamnagar
Gujarat
Jamnagar
GUJARAT
361008
India |
| Phone |
9427776660 |
| Fax |
|
| Email |
anup_thakar@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Praveen Kumar K S |
| Designation |
PhD Scholar |
| Affiliation |
IPGT and RA Jamnagar |
| Address |
Department of Panchakarma
IPGT and RA
Gujarat Ayurved University
Jamnagar
Gujarat
Jamnagar
GUJARAT
361008
India |
| Phone |
9447506528 |
| Fax |
|
| Email |
drpraveenkumarks@gmail.com |
|
|
Source of Monetary or Material Support
|
| IPGT and RA
Gujarat Ayurved university
Near City B Division
Jamnagar pincode 361008 |
|
|
Primary Sponsor
|
| Name |
IPGT and RA Gujarat Ayurved university Jamnagar |
| Address |
Gujarat Ayurved University
Opposite City B Division
Jamnagar
361008 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Praveen Kumar K S |
IPGT and RA Hospital Jamnagar |
Department of Panchakarma
IPGT and RA
Gujarat Ayurved University
Jamnagar
Jamnagar
GUJARAT |
9447506528
drpraveenkumarks@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M543||Sciatica, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Group A |
In this group Vaitarana basti will be given for 16 days accompanied by oral administration of Rasna guggulu, as a Shamana drug in the dose of 500 mg, 2 tablets, thrice/day with warm water as Anupana. Rasna guggulu will be continued after the basti schedule for 14 more days. |
| Intervention |
Group B |
In this group only Vaitarana basti will be given for 16 days after meals. Local abhyanga with bala taila and Nadi sweda will be done before basti. |
| Comparator Agent |
Group C |
In this group oral administration of Rasna guggulu, as a Shamana drug in the dose of 500 mg, 2 tablets, thrice/day with warm water as Anupana is given for 30 days. |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Diagnosed cases of Gridhrasi with symptoms like Ruja, Stambha, Suptata, Spandana, Tandra, Gaurava, Arochaka.
Patients of age group between 20 and 65 years, belonging to both sex.
Patients indicated for basti karma
Willing to sign the consent for study participation.
|
|
| ExclusionCriteria |
| Details |
Uncontrolled diabetes mellitus, hypertension, tuberculosis of spine and hip joint, malignancy of spine or other organs
Fracture related to spine
Cardiac diseases (ischemic heart disease, coronary artery disease, myocardial infarction etc.)
Anemia (hemoglobin % <07.00 mg/dl)
Pregnancy.
Patients contraindicated for basti.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Assessment will be done on the basis of special designed proforma |
7 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Assessment will be done on the basis of special designed proforma |
60 days |
|
|
Target Sample Size
|
Total Sample Size="90"
Sample Size from India="90"
Final Enrollment numbers achieved (Total)= "101"
Final Enrollment numbers achieved (India)="101" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
08/03/2018 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
12/12/2019 |
|
Estimated Duration of Trial
|
Years="2"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
1. K S Praveen Kumar, Thakar Anup, C R Harisha, S Mahesh, VJ Shukla. PHARMACOGNOSTICAL AND PRELIMINARY PHYSICOCHEMICAL EVALUATION OF RASNA GUGGULU. World Journal of Pharmaceutical Research. 2020;9(2):875-882.
2. K S Praveen Kumar, Thakar Anup, C R Harisha, VJ Shukla. PHARMACOGNOSTICAL AND PRELIMINARY PHYSICOCHEMICAL EVALUATION OF VAITARANA BASTI. European Journal of Biomedical and Pharmaceutical sciences. 2020;7(3):343-346. |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
Modification(s)
|
This study was a randomized, parallel group, active
controlled trial comparing the safety and efficacy of Vaitarana Basti
(16 days) and Rasna guggulu 1gms/day (30 days), Vaitarana basti
(16 days) and Rasna guggulu 1 gms/day (30 days) in 101 patients with
Sciatica that was conducted in Panchakarma Hospital, IPGT&RA, Gujarat
Ayurveda University, Jamnagar. The primary outcome measures were assessed on
the basis of relief found in the cardinal features of the disease. Pain by Visual
Analogue Scale, Stambha (stiffness), Suptata (numbness), Spandana
(throbbing/pulsating), Aruchi (anorexia), Tandra (drowsiness), Gaurava
(heaviness) muscle power and Straight Leg Raising are the criteria’s which was assessed
according to their respective standard grading’s before treatment, after
treatment and after follow up period of 4 weeks.
A total of 101 patients were enrolled
for the study and allotted to three groups by randomization sequence. From this
sample 96 patients completed the study and 5 patients discontinued due to
personal reasons. The main findings of the study were: Vaitarana Basti is more effective in managing Vata Kapha
type of Gridhrasi while Rasna guggulu is better for Vatika
type of Gridhrasi. Upon the assessment on effect of therapies, combined
effect of Vaitarana basti and Rasna guggulu provided best results
in comparison to Vaitarana Basti and Rasna guggulu given
separately. Vaitarana basti gave better results than Rasna guggulu
in individual administration of medicines.
|