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CTRI Number  CTRI/2018/12/016727 [Registered on: 19/12/2018] Trial Registered Prospectively
Last Modified On: 12/10/2023
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   Effect of Ayurvedic Medicine in Cervical Spondylosis. 
Scientific Title of Study   Randomized Control Trial on Erandamula Ghanavati With Nasya In Manyagraha With Special Reference To Cervical Spondylosis. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Sunil Gunderao Solanke 
Designation  PG Kayachikitsa 
Affiliation  Government Ayurved College And Hospital, Nagpur. 
Address  Department of kayachikitsa, Government Ayurved College, Ayurvedic Layout, Raghuji nagar, Sakardara chawk,Nagpur.

Nagpur
MAHARASHTRA
440009
India 
Phone  7738339314  
Fax  07122749198  
Email  sunilsolanke6@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Prakash Ramnarayan Kabra 
Designation  M.D. (Kayachikitsa) Professor And HOD 
Affiliation  Government Ayurved College And Hospital, Nagpur. 
Address  Department of kayachikitsa, Government Ayurved College, Ayurvedic Layout, Raghuji nagar, Sakardara chawk,Nagpur.

Nagpur
MAHARASHTRA
440009
India 
Phone  9225226567  
Fax  07122749198  
Email  kabraprakash2711@gmail.com  
 
Details of Contact Person
Public Query  
Name  Prakash Ramnarayan Kabra 
Designation  M.D. (Kayachikitsa) Professor And HOD 
Affiliation  Government Ayurved College And Hospital, Nagpur. 
Address  Department of kayachikitsa, Government Ayurved College, Ayurvedic Layout, Raghuji nagar, Sakardara chawk,Nagpur.

Nagpur
MAHARASHTRA
440009
India 
Phone  9225226567  
Fax  07122749198  
Email  kabraprakash2711@gmail.com  
 
Source of Monetary or Material Support  
Self (Sunil Solanke) Department of Kayachikitssa Government Ayurved college Nagpur  
 
Primary Sponsor  
Name  Solanke Sunil Self  
Address  Government Ayurved college Nagpur 
Type of Sponsor  Other [Self] 
 
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 
Sunil Gunderao Solanke  Government Ayurved Hospital Nagpur  Department of kayachikitsa, Government Ayurved Hospital Nagpur, Ayurvedic Layout, Raghuji nagar, Sakardara chawk,Nagpur.
Nagpur
MAHARASHTRA 		 7738339314
07122749198
sunilsolanke6@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Instistutional Ethical Committee Government Ayurved College Nagpur  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M478||Other spondylosis,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  1) Erandamula Ghanavati 2) Anu Taila for Nasya  Erandamula Ghanavati will be given in the dose of 500mg for each of two times per day with lukewarm water. Anu Tail Nasya administration twice daily. Procedures and assessments will be same as the Comparator Group. 
Comparator Agent  1)Panchatiktaghrita Guggulu : Guduchi, Vasa, Kantakari, Nimba, Patol, Guggulu and Ghrita. 2) Anu Taila for Nasya  All the patients visiting the OPD, IPD and fulfilling criteria of diagnosis X-Ray cervical spine antero-posterior and Lateral view and symptoms of Manyagraha with special reference to Cervical Spondylosis will be admitted in ward or will be treated at O.P.D. level. The detailed history of the patient will be taken as per the case record form and will be recorded. All the symptoms, investigations, will be recorded on the day of admission or at the time of visiting to O.P.D. this day will be considered as day zero. Their status of severity will be noted. All these conditions will be recorded and will be termed as Before Treatment. So, their values will be termed as Before Treatment Values. Panchatiktaghrita Guggulu will be given in the dose of 500mg for each of two times per day with lukewarm water. Anu Tail Nasya administration twice daily. Followed up and assessment done as per fix Schedule. Vital Data will also be recorded. Particular complaints of the patients will be recorded, analysed and will be treated accordingly. Treatment will complete on 21 day and all the parameters will be assessed and recorded which will be denoted as After Treatment values. Investigations of all the patients will also be recorded before and after the treatment and they will be treated as Before and After Treatment scores respectively. In this series of patients of Manyagraha follow up will be taken after 7 days (on 28th day). Follow up assessment will also be done. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  1. Patients having sign and symptoms of Manyagraha according to classics.
2. Radiological changes, degenerative changes in cervical spine.
3. The Oswestry neck disability questionnaire, which has been described in criteria of assessment will be taken in to account.
4. Patient willing and able to participate in the study.
5. Neck pain more than three month.
 
 
ExclusionCriteria 
Details  1)History of any fracture of vertebral joint/ surgical/ diagnostic intervention with reference to affected joints will be excluded.
2)The patient who had fix joint or having developed contracture not be included in study.
3)Patient who are not fit for Nasya.
4) Patient with uncontrolled hypertension (≥160/100mm of Hg) and uncontrolled diabetes (Blood sugar level fasting >150mg/dl and post prandial >250mg/dl) will be ruled out.
5) Patient with evidence of malignancy.
6) Patient on prolonged (≥6weeks) medication with corticosteroids, nonsteroidal anti-inflammatory drug, antidepressants, anticholinergic etc. or any drugs that may influence on the outcome of the study.
7) Patient who have a past history of any other systemic disorders will be excluded.
8) Pregnant / lactating women.
9) Patients who had participated in any other clinical trial since last six months.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Pre-numbered or coded identical Containers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
1)To study effect of oral administration of Erandamula Ghanavati with Anu Taila Nasya particularly on Oswestry Neck Disability Questionnaire and to compare it’s effect with the effect of oral administration of Panchatiktaghrita Guggulu with Anu Tail Nasya.  1)On zero day assessments i.e. B.T. value.
2)For trial Group Panchatiktaghrita Guggulu with Anutail Nasya and for Control Group Erandamula Ghanavati with Anutail Nasya will be given for 21 days
3)Followed up and assessment done on 7th, 14th, 21st day.
4)Final assessment will be done on 28th day
 
 
Secondary Outcome  
Outcome  TimePoints 
1. To study of Manyagraha with reference to Cervical Spondylosis.
2. To study Cervical Spondylosis from modern point of view. 		 One and half year 
 
Target Sample Size   Total Sample Size="104"
Sample Size from India="104" 
Final Enrollment numbers achieved (Total)= "104"
Final Enrollment numbers achieved (India)="104" 
Phase of Trial   Phase 2 
Date of First Enrollment (India)   24/12/2018 
Date of Study Completion (India) 01/06/2020 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details
Modification(s)  		 Sunil Solanke and Prakash Kabra. Randomized control trial on Erandamula ghanavati with nasya in manyagraha with special reference to cervical spondylosis. Int. Res. J. Pharm. 2021;12(6):20-25. http://dx.doi.org/10.7897/2230-8407.1206139 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  

Cervical spondylosis is a general term for age ralated wear and tear affecting the spinal disksin neck.

Spondylosis is caused from years of constant abnormal pressure, caused by joint subluxation, stress induced by sports, acute and/or repetitive trauma, or poor posture, being placed on the vertebrae and the discs between them.

In Ayurveda it can be correlated with Manyagraha as mention by Charak in Shirorogas. As Vata Dosha is mainly responsible for Manyagraha , it’s Treatment should plan according to it.

This is Project entitled “Randomized Control Trial on Erandamula Ghanavati With Nasya in Manyagraha With Special Reference to Cervical Spondylosis”

All the Parameters of assessment will be based on signs and symptoms of Manyagraha, Oswestry Neck Disability Index and Range of movement of neck.

Patients fulfilling the inclusive criteria will be selected and Randomisation done by computational Random Number Generator. All these patients will be divided into two groups called as Trial Group and Control Group by lottery method followed by filling of consent form in language best understood by them. All the Parameters will be assessed before and after treatment based on the specially prepared profarma. Apprppriate test will be apllied to the data outcome and discussion and conclusion will be made accordingly.

 
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