FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2016/11/007474 [Registered on: 17/11/2016] Trial Registered Retrospectively
Last Modified On: 14/06/2017
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Medical Device
Ayurveda 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   MANAGEMENT OF CERVICAL SPONDYLOSIS (ASTHIGATA VATA) WITH YAPANA BASTI & PATRA PINDA SWEDA. 
Scientific Title of Study   RANDOMIZED CLINICAL TRIAL ON BRIHTYADI YAPANA BASTI AND PATRA PINDA SWEDA ALONG WITH AADITYA PAKA GUGGULU IN THE MANAGEMENT OF CERVICAL SPONDYLOSIS W.S.R. TO ASTHIGATA 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 SANGEETA RANI 
Designation  MD AYU SCHOLAR DEPARTMENT OF PANCHAKARMA 
Affiliation  INSTITUTE FOR POST GRADUATE TEACHING AND RESEARCH IN AYURVEDA 
Address  DEPARTMENT OF PANCHAKARMA 4TH FLOOR, INSTITUTE FOR POST GRADUATE TEACHING AND RESEARCH IN AYURVEDA GUJARAT AYURVED UNIVERSITY JAMNAGAR GUJARAT 361008 INDIA
DEPARTMENT OF PANCHAKARMA 4TH FLOOR INSTITUTE FOR POST GRADUATE TEACHING AND RESEARCH IN AYURVEDA GUJARAT AYURVED UNIVERSITY JAMNAGAR GUJARAT 361008 INDIA
Jamnagar
GUJARAT
361008
India 
Phone  9624188940  
Fax    
Email  dr.tanwarsangeeta04@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  PROF ANUP B THAKAR 
Designation  PROFESSOR I/C HEAD OF DEPARTMENT OF PANCHAKARMA 
Affiliation  INSTITUTE FOR POST GRADUATE TEACHING AND RESEARCH IN AYURVEDA 
Address  DEPARTMENT OF PANCHAKARMA 4th FLOOR IPGT & RA GUJARAT AYURVED UNIVERSITY JAMNAGAR GUJARAT
DEPARTMENT OF PANCHAKARMA 4TH FLOOR IPGT & RA GUJARAT AYURVED UNIVERSITY JAMNAGAR GUJARAT
Jamnagar
GUJARAT
361008
India 
Phone  9427776660  
Fax    
Email  anup_thakar@yahoo.com  
 
Details of Contact Person
Public Query
 
Name  DR SANGEETA RANI 
Designation  MD AYU SCHOLAR DEPARTMENT OF PANCHAKARMA 
Affiliation  INSTITUTE FOR POST GRADUATE TEACHING AND RESEARCH IN AYURVEDA 
Address  DEPARTMENT OF PANCHAKARMA 4th FLOOR IPGT & RA GUJARAT AYURVED UNIVERSITY JAMNAGAR GUJARAT
DEPARTMENT OF PANCHAKARMA 4th FLOOR IPGT & RA GUJARAT AYURVED UNIVERSITY JAMNAGAR GUJARAT
Jamnagar
GUJARAT
361008
India 
Phone  9624188940  
Fax    
Email  dr.tanwarsangeeta04@gmail.com  
 
Source of Monetary or Material Support  
INSTITUTE FOR POST GRADUATE TEACHING AND RESEARCH IN AYURVEDA GUJARAT AYURVED UNIVERSITY JAMNAGAR GUJARAT INDIA 361008 
 
Primary Sponsor  
Name  IPGT RA GAU JAMNAGAR GUJARAT 
Address  DEPARTMENT OF PANCHAKARMA IPGT and RA GAU JAMNAGAR GUJARAT 361008 INDIA 
Type of Sponsor  Research institution and hospital 
 
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 SANGEETA RANI  INSTITUTE FOR POST GRADUATE TEACHING AND RESEARCH IN AYURVEDA  DEPARTMENT OF PANCHAKARMA IPGT AND RA GUJARAT AYURVED UNIVERSITY JAMNAGAR GUJARAT 361008
Jamnagar
GUJARAT 
9624188940

dr.tanwarsangeeta04@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  Pain in Cervical region, Numbness and Tingling sensation in hands, Giddiness, Painful and restricted neck movements,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  DEEPANA PACHANA LOCAL ABHYANGA PATRA PINDA SWEDA BRIHTYADI YAPANA BASTI AADITYA PAKA GUGGULU  GROUP A- PATIENTS WILL UNDERGO DEEPANA PACHANA FOR 3-5 DAYS WITH TRIKATU CHOORNA 2-3 GMS BD THEN LOCAL ABHYANGA WITH BALA TAILA PATRA PINDA SWEDA & BRIHTYADI YAPANA BASTI FOR NEXT 16 DAYS FOLLOWED BY AADITYA PAKA GUGGULU AS SHAMANA IN THE DOSE OF 1GM TDS FOR ANOTHER 16 DAYS 
Comparator Agent  DEEPANA PACHANA LOCAL ABHYANGA PATRA PINDA SWEDA AADITYA PAKA GUGGULU  GROUP B- PATIENTS WILL UNDERGO DEEPANA PACHANA WITH TRIKATU CHOORNA 2-3 GMS BD FOR 3-5 DAYS THEN LOCAL ABHYANGA WITH BALA TAILA & PATRA PINDA SWEDA FOR NEXT 16 DAYS FOLLOWED BY AADITYA PAKA GUGGULU AS SHAMANA IN THE DOSE OF 1GMS TDS FOR ANOTHER 16 DAYS 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  PATIENTS HAVING CLINICAL FEATURES OF CERVICAL SPONDYLOSIS
X RAY OF CERVICAL SPINE SHOWING RELEVANT CHANGES OF CERVICAL SPONDYLOSIS 
 
ExclusionCriteria 
Details  PATIENTS HAVING AGE LESS THAN EIGHTEEN AND MORE THAN SIXTY YEARS
PATIENTS WITH ASSOCIATED CONDITIONS LIKE RHEUMATOID ARTHRITIS, ANKYLOSING SPONDYLITIS ETC
SERIOUS ILLNESSES LIKE DM HTN ASTHMA ETC
PREGNANCY 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Improvement in Clinical Profile of Cervical Spondylosis  37 DAYS 
 
Secondary Outcome  
Outcome  TimePoints 
Improved Life quality of Patients  37 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 1/ Phase 2 
Date of First Enrollment (India)   15/01/2016 
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="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details
Modification(s)  
not yet published 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary
Modification(s)  

The present research entitled A Randomized Clinical Trial on Brihatyadi Yapana Basti and Patra Pinda Sweda with Aaditya Paka Guggulu in the management of Cervical Spondylosis wsr to Asthigata Vata is completed. Total 35 patients were registered in the study which were divided into two groups. Group A (BPS- Basti Pindasweda Shamana) patients (n 18) were treated with Trikatu Choorna after which Brihatyadi Yapana Basti along with Patra Pinda Sweda followed by Aaditya Paka Guggulu while in Group B (PS- Pindasweda and Shamana) 17 patients were administered Trikatu Choorna after which Patra Pinda Sweda followed by Aaditya Paka Guggulu, out of which, 16 patients completed the treatment & one dropped out without any specific reason.

Results obtained in BPS group were as Giddiness was relieved by 94.12%, which was Significant (<0.05) statistically. 91.30% relief was seen in Numbness, 88.57% in Stiffness, 80.95% in Tingling sensation & 78.95% relief was present in Headache, which were Highly Significant statistically. Pain was relieved by 72.73%, which was statistically highly significant (<0.001). There was a considerable improvement of 89.29% in Right Lateral Flexion while 87.10% improvement was noticed in Left Lateral Flexion; considerable improvement of 82.93% was seen in Lateral Rotation movement. Flexion & Extension movements also showed remarkable up gradation in movement of 81.82& 67.74% respectively. Statistically, all the parameters of Range of movement showed highly significant improvement (<0.001).68.28% relief was observed in NDI (Neck disability index) Score which was statistically highly significant, 72.92% improvement was found in VA (Visual analogue) Scale, which showed statistically highly significant result (<0.001). Very minor changes were observed in haematological parameters i.e. 5.53%, 3.37%, 1.64% & 0.29% reduction in Total Leucocyte count, Neutrophil, Eosinophil & Haemoglobin respectively while 4.96% & 6.88% rise was found in Lymphocytes & ESR respectively. No change was observed in Monocytes. These changes were statistically non-significant (>0.05). There was a very mild decrease in values of Blood Sugar Level (0.20%) and Serum Calcium level (1.58%) which were statistically insignificant (>0.05). Radiological findings showed 46.15% relief but statistically it was Non-Significant (>0.05).There was 80% improvement noticed in sensory deficit which showed statistically insignificant result. Muscle power improved mildly in almost all the movements involving shoulder, elbow and wrist joints after completion of therapy. However, statistically this improvement was non-significant (P>0.05). There was a considerable improvement in quality of life of patients suffering from Cervical Spondylosis after treatment; 38.25% improvement noticed in mental component scoring & 37.75% in physical component scoring while total Score was improved up to 35.04%. Statistically, highly significant improvement was found in quality of life parameter.

Overall effect of therapy showed moderate improvement in 5.56% of the patients and marked improvement in 66.67% of the patients. Excellent improvement was seen in 27.78% of the patients. None of the patients remained unchanged, no patient got complete remission and none showed mild improvement (Table no 6.45 to 6.55, 6.78).

In PS Group, patients were treated with Trikatu Choorna, Patra Pinda Sweda followed by Aaditya Paka Guggulu. After completion of therapy, tenderness was relieved by 88.89%, stiffness by 87%, pain and numbness each by 75% and headache by 73.68%. All these results were statistically highly significant (<0.001). Statistically significant results (<0.05) were present after treatment in giddiness and tingling sensation, percentage difference being 85.71% and 64.29%, respectively. The movements at cervical spine like flexion, lateral rotation & extension were improved by 80%, 75.86% & 63.16% respectively, which were statistically highly significant (<0.001). Right & left lateral flexion were also improved considerably i.e. 72.41% & 65.38% respectively and statistically, this improvement was significant (<0.05). NDI (Neck disability index) score was reduced by 65.54% which showed statistically highly significant improvement (<0.001).Visual analogue scale was reduced by 70.13%, which was highly significant statistically (<0.001). Minor changes were observed in haematological parameters i.e. 7.65%, 2.22%, 1.54%, 0.82%, 0.08% reduction in Lymphocytes, Monocytes, Haemoglobin, Total Leucocyte count & Eosinophill while 4.65% & 3.64% rise was observed in Neutrophill & ESR respectively but statistically they were non-significant (>0.05) and biochemical parameters like Random Blood Sugar (RBS) & Serum Calcium showed very minor reduction i.e. 2.06% & 0.79% respectively, which were statistically non-significant (>0.05). X-Ray cervical spine showed 40%improvement after treatment but statistically it was non-significant (>0.05).None of the patients reported any sensory deficit before or after the therapy and no change in muscular power was noticed after completion of therapy. While assessing the SF12 criteria for quality of life, mental component scoring (MCS) was found to be improved by 34.75% followed by 31.31% improvement in physical component scoring (PCS). Total 33.33% improvement was observed in quality of life. Statistically, these improvements were highly significant (<0.001).

Overall effect of therapy showed moderate improvement in 12.50% of the patients and marked improvement in 62.50% of the patients while 6.25% patients showed mild improvement & none of the patients remained unchanged and complete cure was not reported by any of the patients.

On comparing both the groups, overall effect of therapy in BPS Group showed better results than PS Group But the difference in effect of therapies was found Non-significant statistically in all the parameters except in muscle power at shoulder level (Shoulder extension & adduction), where BPS group showed better results.

During follow up study, 85.71% of the patients showed no recurrence while the symptoms of the disease recurred in 11.43% of the patients. When seen individually, 94.44% of the patients in BPS group did not complaint of any of the symptom during follow up study and in PS Group, 81.25% of the patients did not report any recurrence.

 
Close