CTRI

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CTRI Number

CTRI/2025/04/085630 [Registered on: 25/04/2025] Trial Registered Prospectively

Last Modified On:

24/04/2025

Post Graduate Thesis

Yes

Type of Trial

Interventional

Type of Study

Drug
Ayurveda

Study Design

Randomized, Parallel Group Trial

Public Title of Study

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

Scientific Title of Study

A Comparative Clinical Study To Evaluate The Efficacy Of Vasadi Kwath With And Without Katibasti (Prasarini Tail) 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	Archana Neelshri Dwiwedi
Designation	Research Scholar
Affiliation	State Ayurvedic College And Hospital, Lucknow
Address	Post Graduate Department Of Kayachikitsa, State Ayurvedic College And Hospital, Tulsidas Marg, Tudiyaganj, Lucknow Lucknow UTTAR PRADESH 226004 India
Phone	8090587850
Fax
Email	neelshri13@gmail.com

Details of Contact Person
Scientific Query

Name	Dr Gurmeet Ram
Designation	Reader
Affiliation	State Ayurvedic College And Hospital, Lucknow
Address	Post Graduate Department Of Kayachikitsa, State Ayurvedic College And Hospital, Tulsidas Marg, Tudiyaganj, Lucknow Lucknow UTTAR PRADESH 226004 India
Phone	9412360556
Fax
Email	gurmeet.dr70@gmail.com

Details of Contact Person
Public Query

Name	Archana Neelshri Dwiwedi
Designation	Research Scholar
Affiliation	State Ayurvedic College And Hospital, Lucknow
Address	Post Graduate Department Of Kayachikitsa, State Ayurvedic College And Hospital, Tulsidas Marg, Tudiyaganj, Lucknow Lucknow UTTAR PRADESH 226004 India
Phone	08090587850
Fax
Email	neelshri13@gmail.com

Source of Monetary or Material Support

State Ayurvedic College And Hospital, Tulsidas Marg, Tudiyaganj, Lucknow

Primary Sponsor

Name	State Ayurvedic College And Hospital Lucknow
Address	Post Graduate Department Of Kayachikitsa, State Ayurvedic College And Hospital, Tulsidas Marg, Tudiyaganj, Lucknow
Type of Sponsor	Government medical college

Details of Secondary Sponsor

Name	Address
NIL	NIL

Countries of Recruitment

India

Sites of Study

No of Sites = 1
Name of Principal Investigator	Name of Site	Site Address	Phone/Fax/Email
Dr Archana Neelshri Dwiwedi	State Ayurvedic College And Hospital Lucknow	Post Graduate Department Of Kayachikitsa, State Ayurvedic College And Hospital, Tulsidas Marg, Tudiyaganj, Lucknow Lucknow UTTAR PRADESH	08090587850 neelshri13@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

Status

Not Applicable

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	Intervention Arm	Drug	Classical		(1) Medicine Name: Vasadi Kwatha, Reference: vangsen vatavyadhi 587, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 40(ml), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 60 Days, anupAna/sahapAna: Yes(details: -erand taila), Additional Information: -
2	Comparator Arm	Procedure	-	kaTibastiH, कटिबस्तिः	(Procedure Reference: keraliya panchkarma, Procedure details: Katibasti will be done in the morning with prasarini taila The patients shall be asked to come for the treatment with light food. The patient will be kept in prone position on a comfortable couch. Finely pounded black gram flour will taken in a sterile bowl, warm water will be added to it and kneaded well so as to prepare a bolus. From this bolus a allwall will be made. The allwall should having a diameter to accommodate and enclose lumbar vertebra, sacro-illiac joint and coccyx with in it. The height of the allwall should be at least 4-5 Angul. The junction of the ring and the skin will be sealed with wet flour. A small amount of oil will then pour in the allwall (compartment) of flour and check for leakage. The Prasarini tail will be heated passively. Required quantity of the tail approximately 200-250 ml (sufficient enough to fill the space within the ring of wet flour) is taken in a small bowl. The bowl will be kept in the vessel filled with hot water. When the oil gets warmed, the bowl will be removed from the water. Oil is poured in the compartment of allwall. Before pouring oil in the compartment the temperature of the oil will be assessed by applying it on the dorsum of hand. Care will be taken to maintain the temperature of the oil in the katibasti pool. The temperature should be kept uniform throughout the procedure (until the procedure is completed). For this, the oil from the pool is removed at regular intervals (leaving some oil in it i.e.oil will not be completely removed) Duration of kati basti is 30 to 45 minutes) (1) Medicine Name: Vasadi kwatha, Reference: vangsen vatavyadhi, Route: Oral, Dosage Form: Kwatha/Kashaya, Dose: 40(ml), Frequency: bd, Duration: 60 Days

Inclusion Criteria

Age From	21.00 Year(s)
Age To	60.00 Year(s)
Gender	Both
Details	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.

ExclusionCriteria

Details

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.

Method of Generating Random Sequence

Computer generated randomization

Method of Concealment

Not Applicable

Blinding/Masking

Open Label

Primary Outcome

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

Secondary Outcome

Outcome	TimePoints
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

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 2

Date of First Enrollment (India)

28/05/2025

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="5"
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

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