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CTRI Number  CTRI/2023/05/053121 [Registered on: 25/05/2023] Trial Registered Prospectively
Last Modified On: 09/10/2023
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   A Clinical Study Of Effect of Virechana Karma in Manyastambha With Special Reference To Cervical Spondylosis. 
Scientific Title of Study   A Randomized Controlled Clinical Trial of Add on Effect of Virechana Karma in Manyastambha With Special Reference To Cervical Spondylosis With Oral Administration of Erandmula Ghanavati And Anutail Nasya 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Vd SNEHA SHANTARAM CHANEKAR 
Designation  Pg Scholar  
Affiliation  Government Ayurveda College And Hospital Vazirabad Nanded  
Address  Room no. 18,Kayachiktsa Department Government Ayurved College,Nanded Nanded MAHARASHTRA 431601 India
Room no. 18,Kayachiktsa Department Government Ayurved College,Nanded Nanded MAHARASHTRA 431601 India
Nanded
MAHARASHTRA
431601
India 
Phone  8888348220  
Fax    
Email  chanekarsneha04@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr V E GOGATE 
Designation  Associate Professor  
Affiliation  Government Ayurveda College And Hospital Nanded. 
Address  Kayachiktsa Department Government Ayurved College Vazirabad Nanded Nanded MAHARASHTRA 431601
Kayachiktsa Department Government Ayurved College Vazirabad Nanded Nanded MAHARASHTRA 431601
Nanded
MAHARASHTRA
431601
India 
Phone  9422214311  
Fax    
Email  vgogate21@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr V E GOGATE 
Designation  Associate Professor  
Affiliation  Government Ayurveda College And Hospital Nanded. 
Address  Kayachiktsa Department Government Ayurved College Vazirabad Nanded Nanded MAHARASHTRA 431601
Kayachiktsa Department Government Ayurved College Vazirabad Nanded Nanded MAHARASHTRA 431601
Nanded
MAHARASHTRA
431601
India 
Phone  9422214311  
Fax    
Email  vgogate21@gmail.com  
 
Source of Monetary or Material Support  
Self sponsored Kayachikitsa Department, Government Ayurveda College, Nanded 
 
Primary Sponsor  
Name  Sneha Shantaram Chanekar  
Address  Room No 18 Kayachiktsa Department Government Ayurveda College And Hospital Vazirabad Nanded 431601 
Type of Sponsor  Other [Self Sponsored ] 
 
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 
Sneha Shantaram Chanekar   Government Ayurvedic College   Government Ayurved College Vazirabad At Post Nanded Dist Nanded MAHARASHTRA 431601
Nanded
MAHARASHTRA 		 8888348220

Chanekarsneha04@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethical Committee   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:M478||Other spondylosis. Ayurveda Condition: MANYASTAMBAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmProcedure-virecana-karma, विरेचन-कर्म Pradhan Karma(Procedure Reference: charak samhita, Procedure details: snehapanottar virechana)
2Comparator ArmDrugClassical(1) Medicine Name: Erandamule ghan vati, Reference: Charak samihita su 26 , Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 14 Days, anupAna/sahapAna: Yes(details: -koshna jal), Additional Information: Nasya With Anutail 8- 8 Drops
 
Inclusion Criteria  
Age From  30.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  1.Patients fit for nasya and virechana karma.
 
 
ExclusionCriteria 
Details  1. Patients with Bahudoshavastha 38

2. Patients with traumatic history of injury to spine.

3. Patients with long term infectious condition.

4. Patients with multiple drug therapy/steroids.

5. Pregnant or lactating women.

6. Critically ill patients. 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Alternation 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To study the add on effect of Snehapurvak Virechana Karma along with oral administration of Erandmul Ghanvati and Anutail Nasya on Manyastambha and Manyashoola with special reference to cervical spondylosis.  14 Days 
 
Secondary Outcome  
Outcome  TimePoints 
1.To compare the efficacy of trial regime with comntrol group in the management of Manyastambha.
2.To evaluate the effect of Virechana on Range Of Motion of neck. 		 14 Days 
 
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)
Modification(s)  		 10/10/2023 
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="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   NIL 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary   This study is randamized , controlled , clinical trial of add on effect of Virechana Karma with Eranadpaya 150ml in Manyastambha with special reference to cervical spindyliosis with oral administration of Erandmul Ghanavati 500mg BD And Anutail Nasya 8°-8° BD for 14 days. This  study is conducted as PG  Course at single centre.The Primary outcome  is to evaluate the effect of  Virechana Karma  in Manyastambha and Manyashoola with special reference to cervical spindyliosis. 
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