FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2024/07/071072 [Registered on: 23/07/2024] Trial Registered Prospectively
Last Modified On: 21/07/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Effectivness Of Shwadrashta Tail Matra Basti In Management Of Katigraha (Lumbar Spondylosis). 
Scientific Title of Study   A Randamize Clinical Control Study To Evaluate The Effect Of Shwadrashta Tail Matra Basti In The Management Of (Nirupstambithita) Katigraha With Special Reference To Lumbar Spondylosis. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Vd Swati Venkat Gawale 
Designation  PG student 
Affiliation  R A Podar Medical (Ayu) College, worli Mumbai 
Address  Panchakarma Department M A Podar Medical(Ayu)College PG girls hostel Worli Mumbai 400018

Mumbai
MAHARASHTRA
400018
India 
Phone  8450937023  
Fax    
Email  gawaleswati@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Vd SEEMA CHAWARDOL 
Designation  MD & PhD Panchakarma HOD & Professor Panchakarma 
Affiliation  M A Podar Medical (Ayu)Hospital Worli Mumbai 
Address  Panchakarma Department, OPD no 7,M A Podar Medical (Ayu) College Worli,Mumbai 400018

Mumbai
MAHARASHTRA
400018
India 
Phone  9881900560  
Fax    
Email  seemabahatkar@gmail.com  
 
Details of Contact Person
Public Query  
Name  Vd Swati Venkat Gawale 
Designation  PG student 
Affiliation  R A Podar Medical (Ayu) College, worli Mumbai 
Address  Panchakarama Department opd no 7 R A Podar Medical(Ayu)College PG girls hostel ,Worli Mumbai 400018

Mumbai
MAHARASHTRA
400018
India 
Phone  8450937023  
Fax    
Email  gawaleswati@gmail.com  
 
Source of Monetary or Material Support  
M A Podar Hospital Worli Mumbai 400018 
 
Primary Sponsor  
Name  R A Podar Medical (Ayu) College ,worli mumbai 
Address  Dr Annie Besant Road ,Worli Mumbai 400018 
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 
Vd Swati Venkat Gawale  M A Podar Hospital Worli Mumbai   Department of Panchakarma M A Podar Hospital Dr Anni Besant Road worli mumbai 400018
Mumbai
MAHARASHTRA 		 8450937023

gawaleswati@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Commitee, R A Podar Medical college (Ayu) And M A Podar Ayurvedic Hospital worli mumbai   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:M471||Other spondylosis with myelopathy. Ayurveda Condition: VATAVYADHIH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Comparator ArmProcedure-saravA~gga, सर्वांग  (Procedure Reference: ch su 5/86, Procedure details: patient is asked to lie in supine position then massage is done all over the body with luke warm oil )
(1) Medicine Name: til taila, Reference: ch su 13/12, Route: Topical, Dosage Form: Taila, Dose: 500(ml), Frequency: od, Duration: 14 Days
2Intervention ArmProcedure-saravA~gga, सर्वांग  (Procedure Reference: ch.su 5/86, Procedure details: Patient is asked to lie in supine position then massage is done all over the body with luke warm oil)
(1) Medicine Name: til taila, Reference: ch.su 13/12, Route: Topical, Dosage Form: Taila, Dose: 500(ml), Frequency: od, Duration: 14 Days
3Intervention ArmProcedure-sa~gkarasvedaH, संकरस्वेदः (Procedure Reference: ch. su 14/43, Procedure details: steam impregnated with ayurvedic decoction is given to the patient all over the body)
(1) Medicine Name: dashmool kwath, Reference: ch.su 14/43, Route: Topical, Dosage Form: Kwatha/Kashaya, Dose: 2000(ml), Frequency: od, Duration: 14 Days
4Intervention ArmProcedure-mAtrAbastiH, मात्राबस्तिः (Procedure Reference: ca.si 3/19, Procedure details: Lubricate the tip of the syringe with oil or ghee. Clean and lubricate the anal orifice with oil and check that there are no hemorrhoids, fissures, or fistulas. Carefully and slowly insert the tip into the rectum and release the clip allowing all the fluid to enter, then remove the tip.)
(1) Medicine Name: shwadrashta tail, Reference: ca chi 28/146, Route: Rectal, Dosage Form: Taila, Dose: 60(ml), Frequency: od, Duration: 14 Days
5Comparator ArmProcedure-sa~gkarasvedaH, संकरस्वेदः (Procedure Reference: ch su 14/43, Procedure details: steam impregnated with ayurvedic decoction is given to the patient all over the body)
(1) Medicine Name: Dashmool kwath, Reference: ch su , Route: Topical, Dosage Form: Kwatha/Kashaya, Dose: 2000(ml), Frequency: od, Duration: 14 Days
6Comparator ArmProcedure-mAtrAbastiH, मात्राबस्तिः (Procedure Reference: ca.si 3/19, Procedure details: Lubricate the tip of the syringe with oil or ghee. Clean and lubricate the anal orifice with oil and check that there are no hemorrhoids, fissures, or fistulas. Carefully and slowly insert the tip into the rectum and release the clip allowing all the fluid to enter, then remove the tip.)
(1) Medicine Name: tila tail, Reference: ch vi 8/150 ch su 13/12, Route: Rectal, Dosage Form: Taila, Dose: 60(ml), Frequency: od, Duration: 14 Days
 
Inclusion Criteria  
Age From  45.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1)Indication of matra basti.
2)Patient fulfilling the selection criteria and between the age of 45 to 60 years.
3)Patient having classical sign and symptoms of katigraha such as pain (shool) and stiffness (stambha).
4)Degenerative changes evident on x Ray LS spine.
 
 
ExclusionCriteria 
Details  1)Fracture of lumber spine
2)Patient who not fit for basti (bleeding piles,rectal prolapse)
3)Children and pregnant women, lactating mothers and during menstrual cycle.
4)Patient with other joint deformity or disease such as TB of spine,spinal abnormality, congenital scoliosis
5)Patient with rheumatoid arthritis will be excluded from study.
6)Patient with immuno compromised disease, psychiatric disease.
7)Patient taking oral pain killers,NSAIDS or ayurvedic drug for pain and patient undergoing any local karma like lepa,upnaha, agnikarma etc.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
There is reduction of VAS (Visual analogue Scale) stiffness grade Indicating reduced pain and Stiffness
2)There is reduction of SLRT (straight leg raise test) and lumbar extention and flextion measurement by goniometer indicated reduced lower back pain  		 5 week to 6 week the pain and stiffness is reduced 
 
Secondary Outcome  
Outcome  TimePoints 
Assessment of stiffness and pain of lower back region  Day 1 and Day 45 
 
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/ Phase 3 
Date of First Enrollment (India)   08/08/2024 
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="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
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  

katigraha is the condition common with aging and is considered to be associated with the low back pain and disability. It is an important clinical, social and public health problem affecting the worldwide population. Aging is well known risk factor of Katigraha as degenerative changes in the spine and disc are one of the major causes of Katigraha.

In this disease pain and stiffness is found to be present at Katipradesh, therefore in purvakarma  Snehana and Swedana are very effective and provide quick result. Bahya  Snehana and Swedana helps in reducing the pain, stiffness of the lumbar spine and increased the blood circulation.

Basti is said to be best treatment for all Vatik disorders. It is highly acclaimed by Aacharya  Charak and described as Ardhachikitsa. Hence an effort is made to evaluate the effect of shwadrashta tail Matra Basti in management of Katigraha.

for an active control til tail is used.

The study is divided into 2 arms-

Intervention arm – matra basti by til tail

comparator arm-matra basti by shwadrashta tail.

The study is single blind (participant blinded).

Randomisation is done using computer software.

30 sample size is taken from each arm making it 60.

The volunteers are asked to do matra basti with shwadrashta  tail 60 ml for 14 days

Assessment done on  1,7,14,30 and 42nd day of treatment 

Assessment will be done on the basis of subjective and objective parameters.


 
Close