A Clinical Study to check the efficacy of vasadi kwath and Katibasti with prasarini taila in gridhrasi with special reference to Sciatica

Phase 2

Not yet recruiting

• Conditions: Sciatica. Ayurveda Condition: GRUDHRASI,

• Registration Number: CTRI/2025/04/085630
• Lead Sponsor: State Ayurvedic College And Hospital Lucknow

Brief Summary

The Present Synopsis entitled-  A COMPARATIVE CLINICAL STUDY TO EVALUATE THE EFFICACY OF VASADI KWATH WITH AND WITHOUT KATIBASTI (PRASARINI TAILA) IN THE MANAGEMENT OF GRIDHRASI w.s.r. to SCIATICA.

AIM

To evaluate the efficacy of Vasadi kwath and katibasti of prasarini tail in the cases of Gridhrasi (Sciatica) To compare the efficacy of Vasadi Kwath with katibasti of prasarini tail in the case of gridhrasi (Sciatica).



OBJECTIVES

PRIMARY OBJECTIVE

To assess the efficacy of trial drug Vasadi kwath with or without katibasti of prasarini tail in the case of gridhrasi w. s.r. Sciatica.



SECONDARY OBJECTIVE

To assess the effectiveness of trial drug in improving the quality of life in patients of GRIDHRASI.

To observe the disease clinically during follow up period with or without drug.

To assess the safety or adverse effect of trial drug.



PLAN OF STUDY-

Study type : Phase II Randomised parallel group study

Duration of trial : 60 days

Sample size : 60 (approximately 10% drop out)



No. of group : Patients are randomly (Sequential) divided and allocated into 2 groups.

Group-A- In this group patients will be treated with Vasadi kwath -40ml twice a day after breakfast/meal along with katibasti of Prasarini taila. (katibasti- the two course of Katibasti with Prasarini taila for 15 days each with gap of 15 days in duration of 60 days.) Group-B- In this group patients will be treated with Vasadi kwath -40ml twice a day after breakfast/ meal.

Followup Period- Studies of all registered cases will be done fortnightly for a period of 60 days with trial drug and 15 days without drug to access the condition of patient and to observe any other side effect.

DURING TREATMENT- D15, D30, D45, D60

AFTER TREATMENT- 15 days without treatment



GROUPING OF PATIENTS

Group-A- In this group patients will be treated with VASADI KWATH-40ml twice a day after breakfast / meal along with katibasti of PRASARINI TAIL. (katibasti- the two course of Katibasti with taila for 15 days each with gap of 15 days in duration of 60 days.)

Ist dose-Ist dose of vasadi kwath will be taken in morning after breakfast/meal II nd dose- II nd dose of vasadi kwath will be taken after 12 hours of first dose.



Group-B- In this group patients will be treated with Vasadi kwath -40ml twice a day after breakfast/meal.

Ist dose- Ist dose of vasadi kwath will be taken in morning after breakfast/meal II nd dose- II nd dose of vasadi kwath will be taken after 12 hours of first dose.



INCLUSION CRITERIA-

1. Age group: 21 - 60 years

2. Socioeconomic status:All

3. Sex:Both Male & Female

4. Subjective criteria- according to ch.chi.28/5 & su.ni.1/74)



Major symptoms-

1. Ruk (Pain)which radiate to sphik, kati, uru,janu, jangha,&pada

2. Sakthi utkshepa nigrahyad (restricted upward lifting of the affected lower limb)



Minor symptoms-

1. Toda (Pricking sensation)

2. Spandan (Throbbing pain)

3. Stambha (decreased/restricted movements of the affected limb)

4. Tandra (Drowsiness)

5. Gaurav (Heaviness)

6. Arochak (Anorexia)



Objective criteria-

1. Positive SLR test/Lasegue’s sign

2. Walking time



Radiological criteria

1. X - ray of the lumbosacral spine in Antero-posterior and lateral positions.

The patients having all 2 major symptoms with one or more minor symptoms and positive SLR test will be selected for this study.



EXCLUSION CRITERIA-

1. Age group less than 21 and greater than 60years will be excluded.

2. Chronicity more than 1 year.

3. Infective conditions and tuberculosis of the spine.

4. Neoplastic & Metastatic conditions of the spine

5. Patients with other systemic disorders and serious illness

6. Pregnancy and lactating mother

7. Patients of complicate case of DM and Hypertension

8. Patients with congenital anomalies and excessive body weight (BMI>35

) 9. Patient refusal

10. Patient with known hypersensitivity to drug under study.

11-Lumbar stenosis/ Lordosis /Kyphosis/Pelvic misalignment lumbar Herniation.

12-. Patient with history of trauma resulting fractures.



Result of the treatment will be assessed on the basis of improvement in terms of-

1. Improvement in terms of Subjective and Objective criteria

2. Recurrence of disease



Result : The total effect of therapy of this trial will be assessed considering following critaria –

1. Improved /Releived

2. Moderate Improvement

3. Mild improvement

4. Not Improved

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2025-04-24
• Study Start: 2025-05-28

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• Major symptoms 1.Ruk which radiate to sphik, kati, uru, janu, jangha, & pada.
• 2.Sakthi utkshepa nigrahyad.
• Minor symptoms 1.Toda 2.Spandan 3.Stambha 4.Tandra 5.Gaurav 6.Arochak Objective criteria 1.Positive SLR test 2.
• Walking time- Time taken to cover 21 metres.
• Radiological criteria 1.
• X-ray of the lumbosacral spine in Antero-posterior and lateral positions.
• The patients having all 2 major symptoms with one or more minor symptoms and positive SLR test will be selected for this study.

Exclusion Criteria

• 1.Age group less than 21 and greater than 60 years will be excluded.
• 2.Chronicity more than 1 year.
• 3.Infective conditions and tuberculosis of the spine.
• 4.Neoplastic & Metastatic conditions of the spine 5.Patients with other systemic disorders and serious illness 6.Pregnancy and lactating mother 7.Patients of complicate case of DM and Hypertension 8.Patients with congenital anomalies and excessive body weight 9.Patient refusal 10.Patient with known hypersensitivity to drug under study.
• 11.Lumbar stenosis or Lordosis or Kyphosis or Pelvic misalignment lumbar Herniation.
• 12.Patient with history of trauma resulting fractures.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Pain (visual analogue scale) Sakthi utkshepa nigrahayad (SLR test)	before trial, 15th day, 30th day, 45th day, 60th day, after trial

Secondary Outcome Measures

Name	Time	Method
1.Toda(pricking sensation), 2.Spandan(Twitching), 3.Stambha(Stiffness), 4.Tandra(Drowsiness), 5.Gaurav(Heaviness) 6.Arochak(anorexia) 7.Walking time	before trial, 15th day, 30th day, 45th day, 60th day, after trial

Trial Locations

Locations (1)

State Ayurvedic College And Hospital Lucknow; 🇮🇳 Lucknow, UTTAR PRADESH, India

State Ayurvedic College And Hospital Lucknow

🇮🇳Lucknow, UTTAR PRADESH, India

Dr Archana Neelshri Dwiwedi

Principal investigator

08090587850

neelshri13@gmail.com