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
|
|
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
|
|
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. |