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CTRI Number  CTRI/2022/12/048545 [Registered on: 27/12/2022] Trial Registered Prospectively
Last Modified On: 27/12/2022
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Ayurvedic management of katigraha( lumbar spondylosis) 
Scientific Title of Study   “Randomized Controlled Trial on Synergistic Effect of Vatari Guggulu, Panchatikta Ksheerbasti and Katibasti in Katigrah with Special Reference to Lumbar Spondylosis.” 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Ramraj singh 
Designation  PG Scholar 
Affiliation  Goverment Ayurved College, Nagpur 
Address  Kayachikitsa Department, 2 nd Floor, Government Ayurved College and Hospital, Sakkardara Square, Nagpur Nagpur MAHARASHTRA 440024 India

Nagpur
MAHARASHTRA
440024
India 
Phone  7999912473  
Fax    
Email  ramrajsingh0625@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Jayant Gulhane  
Designation  Associate Professor  
Affiliation  Goverment Ayurved College, Nagpur 
Address  Kayachikitsa Department, 2 nd Floor, Government Ayurved College and Hospital, Sakkardara Square, Nagpur

Nagpur
MAHARASHTRA
440024
India 
Phone  9822922399  
Fax    
Email  jayant.gulhane.62.6@gmail.com  
 
Details of Contact Person
Public Query  
Name  Ramraj singh 
Designation  PG Scholer 
Affiliation  Government Ayurved College, Nagpur 
Address  Kayachikitsa Department, 2 nd Floor, Government Ayurved College and Hospital, Sakkardara Square, Nagpur

Nagpur
MAHARASHTRA
440024
India 
Phone  7999912473  
Fax    
Email  ramrajsingh0625@gmail.com  
 
Source of Monetary or Material Support  
Government Ayurved college , Nagpur 
 
Primary Sponsor  
Name  Ramraj Singh 
Address  Department of Kayachikitsa Government Ayurveda College,Raje Raghuji nagar, Sakkardara square Nagpur 
Type of Sponsor  Other [Post Graduate student] 
 
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 
Ramraj Singh  Government Ayurveda College And Hospital, Nagpur  Kayachikitsa Department,2 nd floor, Government Ayurved College and Hospital, Raghuji Nagar, Sakkardara Square, Nagpur 440024 Nagpur MAHARASHTRA
Nagpur
MAHARASHTRA 		 7999912473

ramrajsingh0625@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Comittee Government Ayurved College and Hospital Nagpur  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:M472||Other spondylosis with radiculopathy. Ayurveda Condition: VATAVYADHIH, (2) ICD-10 Condition:M199||Osteoarthritis, unspecified site. Ayurveda Condition: PRUSHTHA-GRAHAH (KEVALAVATA),  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmDrugClassical(1) Medicine Name: vatari guggul, Reference: bhaisajyaratnavali ch.21/ 154, Route: Oral, Dosage Form: Guggulu , Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: -koshna jal), Additional Information: -
2Intervention ArmProcedure-bastikarma/vastikarma, बस्तिकर्म/वस्तिकर्म (Procedure Reference: Ashtang Hridyam kalpasthan 4, Procedure details: The drug will be taken in quantity as given here with. Panchatikata [30] 20gm, water 240ml, Kshira 240ml, as per the ratio used while making the Kshirapaka [31] . Then the 22 content will be heated on steady flame (Madhyamagni). The heat will be given up to the extent that the quantity of water used will get vaporised and only milk i.e. Kshira will remain. By this time all the medicinal properties present in the Panchatikta will get homogenised with that of milk. Now this processed milk ()
3Comparator ArmDrugClassical(1) Medicine Name: erandamul ghanvati, Reference: charak samhita sutrasthan, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: -koshnajal), Additional Information: -
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  1.Patients of either sex aged between 18- 70 years irrespective of caste, religion, socioeconomic & educational status.
2.The Roland and Morris disability questionnaire; if RDQ score> 5
3.Radiological degenerative changes in Lumbar spine.
4.Patients having sign and symptoms of Katigrah according to classics.
5.Patient willing and able to participate in the study.
6.Chronic low back pain more than three months.
 
 
ExclusionCriteria 
Details  1.History of any fracture of vertebral joint/ surgical/ diagnostic intervention with reference to affected joints will be excluded.
2.Gross disability in performing daily normal routine i.e. bedridden patient or confined to a wheelchair will be excluded.
3.Patient with co-morbidities such as gouty arthritis, rheumatoid arthritis or psoriatic arthritis and tubercular arthritis.
4.Patient with any deformity of hip or back altering the gait and posture of the patient, ankylosing spondylitis, pelvic inflammatory disorders.
5.Patient with uncontrolled hypertension and uncontrolled diabetes will be ruled out.
6.Patient with evidence of malignancy.
7.Patient on prolonged (≥6weeks) medication with corticosteroids, non-steroidal anti-inflammatory drug, antidepressants, anti-cholinergic etc. or any drugs that may influence on the outcome of the study.
8.Pregnant / lactating women.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   On-site computer system 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
1.To Evaluate the synergistic effect of Vatari Guggulu, Panchatikta Kshira Basti along with Kati Basti particularly on the Rolland and Morris disability questionnaire and clinical features of Katigrah with special reference to Lumbar Spondylosis.
2.To compare the effect of Vatari Guggulu, Panchatikta Kshira Basti along with Kati Basti with Erandamula Ghanavati , Panchatikta Kshira Basti along with Kati Basti particularly on Rolland Morris Index.
 		 35 Days 
 
Secondary Outcome  
Outcome  TimePoints 
WOMAC Score
VAS Score
 		 35 Days 
 
Target Sample Size   Total Sample Size="98"
Sample Size from India="98" 
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)   05/01/2023 
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="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   Nil 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response - Informed Consent Form
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [ramrajsingh0625@gmail.com].

  6. For how long will this data be available start date provided 05-01-2023 and end date provided 05-01-2026?
    Response - Beginning 9 months and ending 36 months following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary  

After clearance from Institutional Ethics Committee of Government Ayurved college,Nagpur, Patient visited to OPD, IPD; Casualty with complaints of low back pain,  were recruited from OPD and IPD of Government Ayurved College, Nagpur.

  During the informed consent process the subjects were given enough time to read patient information sheet  and consent form.(ICF)subjects were also given freedom to ask the questions and all the questions were answered. If he/she agrees for participation in the study and if found fit to include during screening then he was recruited in the study. This visit was called as screening visit.

  On screening visit, after written informed consent, screening of subject on the basis of clinical assessment for katigrha (i.e. lumbar Spondylosis) and fulfilling the diagnostic criteria . If all inclusion criteria is YES and all exclusion NO then subjects will be included on the basis of criteria given as  Roland Morris low back pain and disability questionnaire and X-Ray Lumbosacral Spine

  Subjects were then undergo general and systemic examinations. Clinical symptoms  Katigrah was assessed along with VAS and WOMAC scale and recorded in the CRF . Study design will be Parallel Group Randomised Control Trial

Parallel study design of Groups and Drugs Given in Respective Groups

.Table-1

   

Group Trial

Group Control

0 Day assessment (Before treatment) on admission day

0 Day assessment (Before treatment) on admission day

Pachana for 5 days

pachana for 5 days

Assessment  On 6 day

Assessment   On 6 day

Local application of Katibasti followed by Administration of Panchatikta kshira  Basti along with oral administration of Vatari Guggulu. .

 Local application of Katibasti followed by Administration of Panchatikta kshira Basti along with oral administration of  Erandmula Ghanavati.

Assessment On 16 day

Assessment  On 16 day

Assessment after completion of treatment.

Assessment after completion of treatment.

 

Duration of Basti : 15 days

Duration of Shamana Dravya: 30 days


Treatment Regimen:

 

Trial Group

 

Table-2

Treatment given

Duration

Dose

Anupana

Bheshaja

Sevankala

 

 Vatari  Guggulu

30 days

500mg BD

Ushnodak

Apankal

 Til tail Katibasti

15days

 

200 ml

 ----

Morning hour 9-10 am

Panchatikta Kshirabasti

15 days

240 ml

----

Paschat bhakta  once  a day morning time

(11 to 11:30am)                  

                                                      

Control Group

Table-3

Treatment given

Duration

Dose

Anupana

Bheshaja

Sevankala

 

 Erandamula Ghanavati

30 days

500mg BD

Ushnodak

Apankal

 Til Tail Katibasti

15days

 

200 ml

----

Morning hour 9-10 am

Panchatikta Kshirabasti

15 days

240 ml

----

Paschat bhakta  once  a day morning time

(11 to 11:30am)                  

 

 

 



 

 

 

 

 

 

 

 

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