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Clinical Trials/CTRI/2018/03/012346
CTRI/2018/03/012346CompletedPhase 3

Assessment Of Vaitarana Basti And Rasna Guggulu In The Management Of Pain In Gridhrasi (Sciatica) A Randomized Controlled Clinico Experimental Study

IPGT and RA Gujarat Ayurved university Jamnagar1 site in 1 country90 target enrollmentStarted: August 3, 2018Last updated:
Conditions

Trial Snapshot

Phase
Phase 3
Status
Completed
Sponsor
Enrollment
90
Locations
1
Primary Endpoint
Assessment will be done on the basis of special designed proforma

Study Overview

Brief Summary

This study was a randomized, parallel group, activecontrolled 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 withSciatica that was conducted in Panchakarma Hospital, IPGT&RA, GujaratAyurveda University, Jamnagar. The primary outcome measures were assessed onthe basis of relief found in the cardinal features of the disease. Pain by VisualAnalogue 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 assessedaccording to their respective standard grading’s before treatment, aftertreatment and after follow up period of 4 weeks.

A total of 101 patients were enrolledfor the study and allotted to three groups by randomization sequence. From thissample 96 patients completed the study and 5 patients discontinued due topersonal reasons. The main findings of the study were: Vaitarana Basti is more effective in managing Vata Kaphatype of Gridhrasi while Rasna guggulu is better for Vatikatype of Gridhrasi. Upon the assessment on effect of therapies, combinedeffect of Vaitarana basti and Rasna guggulu provided best resultsin comparison to Vaitarana Basti and Rasna guggulu givenseparately. Vaitarana basti gave better results than Rasna gugguluin individual administration of medicines.

Study Design

Study Type
Interventional
Allocation
Computer generated randomization
Masking
Open Label

Eligibility Criteria

Ages
20.00 Year(s) to 65.00 Year(s) (—)
Sex
All

Inclusion Criteria

  • •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.

Exclusion Criteria

  • •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.

Outcomes

Primary Outcomes

Assessment will be done on the basis of special designed proforma

Time Frame: 7 days

Secondary Outcomes

  • Assessment will be done on the basis of special designed proforma(60 days)

Investigators

Sponsor
IPGT and RA Gujarat Ayurved university Jamnagar
Sponsor Class
Research institution and hospital

Study Sites (1)

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