| CTRI Number |
CTRI/2025/10/095521 [Registered on: 01/10/2025] Trial Registered Prospectively |
| Last Modified On: |
01/10/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
In this study patient with GRIDHRASI wsr SCIATICA will be selected to compare the relief in pain through KATI BASTI with BALA TAILA and BALAMOOLA KASHAYA |
|
Scientific Title of Study
|
A RANDOMIZED COMPARATIVE CLINICAL STUDY TO EVALUATE THE
EFFECT OF KATI BASTI WITH BALA MOOLA KASHYA AND BALA TAILA IN THE MANAGEMENT OF GRIDHRASI wsr TO SCIATICA |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DR AKANKSHA GAUR |
| Designation |
PG SCHOLAR |
| Affiliation |
SDM AYURVEDIC COLLEGE, HOSPITAL AND RESEARCH CENTER |
| Address |
Department of Panchakarma
SDM college of ayurveda hospital and research center Laxmi Nagar Kuthpady Udupi
Udupi
KARNATAKA
574118
India |
| Phone |
9780057669 |
| Fax |
|
| Email |
dr.akankshagaur25@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR MANJUNATH KANTHI |
| Designation |
ASSISTANT PROFESSOR |
| Affiliation |
SDM AYURVEDIC COLLEGE, HOSPITAL AND RESEARCH CENTER |
| Address |
Department of Panchakarma
SDM college of ayurveda hospital and research center Laxmi Nagar Kuthpady Udupi
Udupi
KARNATAKA
574118
India |
| Phone |
9844469138 |
| Fax |
|
| Email |
kanthipk03@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR MANJUNATH KANTHI |
| Designation |
ASSISTANT PROFESSOR |
| Affiliation |
SDM AYURVEDIC COLLEGE, HOSPITAL AND RESEARCH CENTER |
| Address |
Department of Panchakarma
SDM college of ayurveda hospital and research center Laxmi Nagar Kuthpady Udupi
Udupi
KARNATAKA
574118
India |
| Phone |
9844469138 |
| Fax |
|
| Email |
kanthipk03@gmail.com |
|
|
Source of Monetary or Material Support
|
| SDM AYURVEDIC COLLEGE, HOSPITAL AND RESEARCH CENTER, LAXMINAGAR, KUTHPADY, UDUPI,KARNATAKA, INDIA 574118 |
|
|
Primary Sponsor
|
| Name |
SDM college of ayurveda hospital and research center |
| Address |
Laxmi Nagar Kuthpady Udupi, KARNATAKA |
| Type of Sponsor |
Private medical college |
|
|
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 AKANKSHA GAUR |
SDM college of ayurveda hospital and research center |
Laxmi Nagar Kuthpady Udupi
Udupi
KARNATAKA |
9780057669
dr.akankshagaur25@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE SDM COLLEGE OF AYURVEDA UDUPI |
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 | Intervention Arm | Procedure | - | kaTibastiH, कटिबस्तिः | (Procedure Reference: , Procedure details: KATI BASTI WITH BALAMOOLA TAILA
POORVA KARMA
1. Preparation of Therapy –
• Procure all necessary materials for Kati Basti.
• Prepare a dough of black gram flour.
2. Preparation of Patient –
• Assess fitness based on Indications & Contraindications.
• Daily fitness check :
• Examine for boils.
• Assess severity of pain.
• Look for signs of infection & inflammation.
Provide counselling to the patients –
• Explain the administration/procedure.
• Clarify the timing of the treatment.
PRADHANA KARMA
1. Check for the tenderness in the Kati Pradesha.
2. Black gram flour dough has to be prepared & rolled in the form of an elongated
tubular structure.
11
3. Place the dough in Kati Pradesha in a circular manner approximately having 8-10 cm
diameter & 5 – 6 cm in height.
4. Now the oil is heated up to tolerant capacity of the patient by indirect method of
heating & poured.
5. Initially oil should be poured along the sides of the dough.
6. Care should be taken to maintain the constant temperature of the oil.
7. Reheating of the oil has to be done by leaving some amount of the oil inside the frame
of the dough.
8. The same procedure has to be repeated for 30 minutes.
9. Total duration of the procedure will be carried out for 7 days.
PASCHAT KARMA
1. After 30 minutes, oil is taken out with the help of spoon in a container.
2. Dough is taken out & the remnant oil over the low back area will be massaged
gently. )
| | 2 | Comparator Arm | Procedure | - | kaTibastiH, कटिबस्तिः | (Procedure Reference: , Procedure details: POORVA KARMA
1. Preparation of Kwatha -
• Bala Moola Kwatha Churna is taken & added to 16 parts of water.
• Boiling is continued until total quantity of water is reduced to 1/8th.
• This is then filtered & used.
2. Preparation of Therapy –
• Procure all necessary materials for Kati Basti.
• Prepare a dough of black gram flour.
3. Preparation of Patient –
• Assess fitness based on Indications & Contraindications.
• Daily fitness check :
• Examine for boils.
• Assess severity of pain.
• Look for signs of infection & inflammation.
Provide counselling to the patients –
• Explain the administration/procedure.
• Clarify the timing of the treatment.
PRADHANA KARMA
1. Check for the tenderness in the Kati Pradesha.
2. Black gram flour dough has to be prepared & rolled in the form of an elongated
tubular structure.
3. Place the dough in Kati Pradesha in a circular manner approximately having 8-10
cm diameter & 5 – 6 cm in height.
4. Now the Bala Moola Kashaya is heated up to tolerant capacity of the patient by
indirect method of heating & poured.
5. Initially Kashaya should be poured along the sides of the dough.
6. Care should be taken to maintain the constant temperature of the Kashaya.
7. Reheating of the Kashaya has to be done by leaving some amount of the Kashaya
inside the frame of the dough.
8. The same procedure has to be repeated for 30 minutes.
9. Total duration of the procedure will be carried out for 7 days.
PASCHAT KARMA
1. After 30 minutes, Kashaya is taken out with the help of spoon in a container.
2. Dough is taken out & the remnant Kashaya over the low back area will be
massaged gently.)
|
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Lakshanas of Gridhrasi
Stambha, Ruk, Toda, Tandra, Gaurava, Arochaka
Spandana in Sphik, Kati, Prista, Uru, Janu, Jangha, Pada
Signs &Symptoms of Sciatica:
Pain in the low back, radiating to the buttocks, downward into the leg.
Burning and tingling sensations in leg. Increase of pain on Coughing, sneezing and other sudden movements |
|
| ExclusionCriteria |
| Details |
Congenital deformities of lumbar spine.
Traumatic conditions of lumbar spine.
Infective conditions of the lumbar spine
Neoplastic conditions of the lumbar spine
Post-surgical conditions of lumbar spine
Pregnant women
Any other systemic illness interfering with the treatment. |
|
|
Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Samyak Swinna lakshana.
Symptoms of Gridhrasi/ Sciatica.
|
0, 7 AND 14 DAY |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
straight leg raising test
Lassegue’s test (Bowstring sign)
Schober’s test
Patients will be evaluated based on the following scoring methods:
Visual numerical rating scale
Greenough and Fraser scoring method |
0, 7 AND 14 DAY |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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/ Phase 3 |
|
Date of First Enrollment (India)
|
16/10/2025 |
| 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="2"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Open to Recruitment |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
THIS IS AN OPEN LABEL RANDOMISED COMPARATIVE CLINICAL STUDY TO EVALUATE THE EFEECT OF BALAMOOLA KASHAYA AND BALA TAILA IN THE MANAGAEMENT OF GRIDHRASI W.S.R. TO SCIATICA. IN THIS THE TWO DRUGS COMPARED ARE BALAMOOLA KASHAYA AND BALA TAILA. THE PRIMARY OUTCOMES OF THE STUDY ARE SAMYAK SWINNA LAKSHANA, SYMPTOMS OF GRIDHRASI/SCIATICA AND SECONDARY OUTCOMES ARE STRAIGHT LEG RAISING TEST LASSGUES TEST (BOWSTRING SIGN) SCHOBERS TEST. ON DAY 0, 7 AND 14 |