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CTRI Number  CTRI/2022/03/041389 [Registered on: 25/03/2022] Trial Registered Prospectively
Last Modified On: 23/03/2022
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Non-randomized, Multiple Arm Trial 
Public Title of Study   CLINICAL STUDY OF SHIVA GUGGULU AND VAJIGANDHADI TAILA IN LOWER BACK PAIN 
Scientific Title of Study   Role Of Shiva Guggulu & Vajigandhadi Taila In The Clinical Management Of Katigata vata 
Trial Acronym  - 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr varsha singh 
Designation  Pg scholar in department of kayachikitsa 
Affiliation  Shri narayana prasad awasthi government ayurveda college raipur chhattisgarh 492010 India  
Address  Shri Narayan Prasad Awasthi Government Ayurveda College Raipur Chhattisgarh 492010 India

Raipur
CHHATTISGARH
492010
India 
Phone  9584731872  
Fax    
Email  varshapendra@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Aruna Ojha 
Designation  Professor kayachikitsa and HOD of kayachikitsa 
Affiliation  Shri narayana prasad awasthi government ayurveda college raipur chhattisgarh 492010 India  
Address  Shri Narayan Prasad Awasthi Government Ayurveda College Raipur Chhattisgarh 492010 India

Raipur
CHHATTISGARH
492010
India 
Phone  9424401858  
Fax    
Email  arunaojha90@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Jeevan Lal Sahu  
Designation  Lecturer in department of kayachikitsa 
Affiliation  Shri narayana prasad awasthi government ayurveda college raipur chhattisgarh 492010 India  
Address  Shri Narayan Prasad Awasthi Government Ayurveda College Raipur Chhattisgarh 492010 India

Raipur
CHHATTISGARH
492010
India 
Phone  8824099797  
Fax    
Email  jeev.dr@gmail.com  
 
Source of Monetary or Material Support  
Department of Kayachikitsa Shri Narayana Prasad Awasthi Government Ayurveda College Raipur Chhattisgarh 492010 
 
Primary Sponsor  
Name  Department of kayachikitsa government ayurveda college raipur chhattisgarh 
Address  Shri Narayan Prasad Awasthi Government Ayurveda College Raipur Chhattisgarh 492010 India  
Type of Sponsor  Other [Shri Narayan Prasad Awasthi Government Ayurveda College Raipur Chhattisgarh 492010 India] 
 
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 Varsha Singh  Shree Khudadad Dungaji Goverment Ayurved Hospital Raipur Chhattisgarh  OPD NO.2,18 AND IPD Patients Department Of Kayachikitsha
Raipur
CHHATTISGARH 		 9584731872

varshapendra@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee office of the principal, shri narayan prasad awasthi govt. ayurved college Raipur c.g.  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:M498||Spondylopathy in diseases classified elsewhere. Ayurveda Condition: katigata vata ,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Comparator ArmDrugClassical(1) Medicine Name: SHIVA GUGGULU , Reference: RASENDRASARA SANGRA AAMVAT CHIKITSA 18/21, Route: Oral, Dosage Form: Guggulu , Dose: 1(g), Frequency: qid, Bhaishajya Kal: Adhobhakta, Duration: 30 Days, anupAna/sahapAna: No, Additional Information: SHIVA GUGGULU COMMEN IN BOTH GROUP
(2) Medicine Name: VAJIGANDHADI TAIL, Reference: YOGRATNAKAR VATAVYADHI CHIKITSA CHAPTER 2, Route: Rectal, Dosage Form: Taila, Dose: 60(ml), Frequency: od, Bhaishajya Kal: Adhobhakta, Duration: 30 Days, anupAna/sahapAna: No, Additional Information: VAJIGANDHADI TAIL USE IN BOTH GROUP GROUP A MATRA BASTI GROUP B KATI BASTI
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  Based On Clinical Symptoms Maintioned In Classical Text Book Of Ayurveda And Modern. 
 
ExclusionCriteria 
Details  Patient Of Age Group Below 18 Yrs To Above 70 Year.
Tb Spine/Hip. Paraplegia And Monoplegia Because Of Any Cause.
Pregnant Women And Lactating Mother. Neoplasm Of Spinal Cord.
Complicated Spinal Disorders- Lordosis, Scoliosis, Kyphosis.
Terminal Illness Such As Carcinoma, AIDS, Leukemia.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Reduce The Symptoms Of Katigata Vata  1 month 
 
Secondary Outcome  
Outcome  TimePoints 
improve the quality of life.  1 month 
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
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   N/A 
Date of First Enrollment (India)   01/04/2022 
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="0"
Months="1"
Days="30" 
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 - NO
Brief Summary  
Ayurveda is an ancient Medicine System of the Indian subcontinent.  According to Ayurveda the human body is composed of four basics the dosha, dhatu, mala and Agni these is immense significance of all this basis of the body in Ayurveda these are also called Mool Siddhant or the basic fundamental of Ayurvedic treatment.
 The description about is Katigata Vata is not available as a separate disease entity in any ayurvedic text. It is mentioned as one of the Vatavyadhi in charak samhita (eighty nanatmaja vatavyadhi)
Katigata Vata is correlated with Lumbosacral spine disease.
Allopathy has analgesics, anti-inflammatory agents, corticosteroids, muscle relaxant, traction’s  to offer. But these drugs has obvious side effect which limits there use for long periods. So i have decided to take matra basti and kati basti by "Vajigandhadi Taila" and Abhyantar use of Shiva Gugglu in Katigata Vata.

 
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