| CTRI Number |
CTRI/2019/03/018321 [Registered on: 29/03/2019] Trial Registered Prospectively |
| Last Modified On: |
27/03/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A Comparative Study to evaluate the efficacy of Agnikarma with Tamra Shalaka and Panchdhatu Shalaka in Management of Cervical Spondylosis. |
|
Scientific Title of Study
|
‘A Randomized Controlled clinical trial to evaluate the efficacy of Agnikarma with Tamra Shalaka and Panchdhatu Shalaka in management of Manya Sandhigata 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 Tejaswini Baban Sawant |
| Designation |
PG second year |
| Affiliation |
PDEAs college of ayurved and research center, Nigdi, Pune |
| Address |
Department Shalyatantra OPD no. 123, Ayurved Rugnalaya and Sterling Multispeciality Hospital, Sector no.27, Pradhikaran, Nigdi, Pune.
Pune
MAHARASHTRA
411044
India |
| Phone |
7710055224 |
| Fax |
|
| Email |
tejaswini.sawant93@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Bhalchandra N Deshpande |
| Designation |
HOD Shalyatantra Department |
| Affiliation |
PDEAs college of ayurved and research center, Nigdi, Pune |
| Address |
Department Shalyatantra OPD no. 123, Ayurved Rugnalaya and Sterling Multispeciality Hospital, Sector no.27, Pradhikaran, Nigdi, Pune.
Pune
MAHARASHTRA
411044
India |
| Phone |
9970108596 |
| Fax |
|
| Email |
dr.bhdeshpande@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Bhalchandra N Deshpande |
| Designation |
HOD Shalyatantra Department |
| Affiliation |
PDEAs college of ayurved and research center, Nigdi, Pune |
| Address |
Department Shalyatantra OPD no. 123, Ayurved Rugnalaya and Sterling Multispeciality Hospital, Sector no.27, Pradhikaran, Nigdi, Pune.
Pune
MAHARASHTRA
411044
India |
| Phone |
9970108596 |
| Fax |
|
| Email |
dr.bhdeshpande@gmail.com |
|
|
Source of Monetary or Material Support
|
| PDEAs college of ayurved and research center Sector no. 25 Pradhikaran Nigdi Pune |
|
|
Primary Sponsor
|
| Name |
PDEAs college of ayurved and research center |
| Address |
sector no 25 Pradhikaran Nigdi Pune |
| Type of Sponsor |
Private medical college |
|
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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 Tejaswini Baban Sawant |
Ayurved Rugnalaya and Sterling Multispeciality hospital |
Sector no 27 Pradhikaran Nigdi Pimpri Chinchwad
Pune 411044
Pune
MAHARASHTRA |
771055224
tejaswini.sawant93@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committe |
Approved |
|
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Regulatory Clearance Status from DCGI
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M478||Other spondylosis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Agnikarma with Panchadhatu Shalaka |
Samyak Dagdha Vrana (therapeutic superficial burn) over the back of neck at marked most tender or most painful site with heated Panchadhatu shalaka will be done only once at a time on 0th day and 7th day.
Then on 15th and 30th day assessment of patient will be done to see any reoccurence of any symptoms.
Further results will be compared of both groups. |
| Intervention |
Agnikarma with Tamra Shalaka |
Samyak Dagdha Vrana (therapeutic superficial burn) over the back of neck at marked most tender or most painful site with heated Tamra shalaka will be done only once at a time on 0th day and 7th day.
Then on 15th and 30th day assessment of patient will be done to see any reoccurence of any symptoms.
|
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
A) Patients having symptoms of Cervical Spondylosis
B) Patients with Sandhigata Vata (Manyagata) Lakshanas :
Shool (pain),
Shotha (swelling),
Atopa (grating),
Sthambh (Stiffness)
Sandhihata (restricted movements)
C) Related symptoms like;
Bhrama (Giddiness),
Shirashool (headache),
Chimchimayan Hasta (tingling sensation in hands)
Suptata (numbness).
D) Patients who will give written consent for the trial,irrespective of Gender, Religion, Occupation, Socio-economic status. |
|
| ExclusionCriteria |
| Details |
Known cases of:
a) Skin diseases and localized wounds.
b) Tuberculosis of spine (Pott’s spine),
c) Diabetic Neuropathy,
d) HIV and HBsAg positive patients,
e) Rheumatoid Arthritis, Gouty Arthritis, Psoriatic Arthritis,
f) Ischemic Heart Disease,
g) History of injury, fracture, surgery to Spine and Cervical Spondylolisthesis
h) Congenital anomalies of spine
I) Carcinoma of Spine.
|
|
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Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the effect of Agnikarma with Tamra Shalaka and Panchadhatu Shalaka in management of Manya Sandhigata Vata with special reference to Cervical Spondylosis. |
1. On 0 and 7th Day agnikarma will be performed and observations will be noted.
2. On 15th day and 30th day, follow up with assessment to rule out any reoccurrence of complaints. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. To study the efficacy of Agnikarma with Tamra Shalaka in management of Manya Sandhigata Vata with special reference to Cervical Spondylosis.
2. To study the efficacy of Agnikarma with Panchadhatu Shalaka in management of Manya Sandhigata Vata with special reference to Cervical Spondylosis.
3. To observe adverse effect if any. |
1. On 0 and 7th Day agnikarma will be performed and observations will be noted.
2. On 15th day and 30th day, follow up with assessment to rule out any reoccurrence of complaints. |
|
|
Target Sample Size
|
Total Sample Size="68"
Sample Size from India="68"
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)
|
15/04/2019 |
| 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="6"
Days="10" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
not yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
In present era, peoples are prone to many neck related problems because of lifestyle, improper and professionally adopted postures, food habits, stress, travelling, etc. which may develop symptoms of cervical Spondylosis. It can be correlated with the Sandhigata Vata (Manyagata) in Ayurveda which is one of Vatavyadhis. The management of the symptoms is done by using steroids, analgesics, and anti-inflammatory drugs in day to day life. It is observed that these treatments does not give long term relief and may produce adverse effects. As structural changes are permanent but a treatment which will provide symptomatic relief to perform regular work without any complications is the need of the hour.
Cervical Spondylosis is an age related chronic degenerative disorder of intervertebral disc and bodies of cervical spines.
Degenerative changes are common in the cervical spine. Indeed they are found almost universally in some degrees in persons over 50 years of age. Nowadays joint disorders are prevailing even in early age group after 3rd decade of life. About 50% of people over the age of 40-45 experience neck pain and stiffness and symptoms of cervical Spondylosis.
Repeated trauma related to specific occupation like carrying axial loads, professionally adopted postures, etc. and smoking plays important role in producing Cervical Spondylosis even in lesser groups. It shows symptoms like pain, stiffness of neck, sometimes with referred symptoms in an upper limb like tingling, numbness, radiating pain in the course of nerve.
As structural changes are clearly permanent, only symptomatic relief can be provided by administration of powerful analgesics and another conventional tools available in modern medicine like Ultrasound, Short-wave diathermy, massage and intermittent traction. Physiotherapy and strengthening exercises shown some benefits. All been used but none have shown to be effective in large clinical trials. Surgical procedures like laminectomy, cervical arthrodosis, etc. Are good but expensive and may show postoperative complications.
According to Acharyas, Sandhi (joints) is sthana of kapha dosha. Kaphavritta Vyana Vayu is a chief causative factor to produce pain and restricted movements of joints.
Kaphavritta Vyan Vayu is responsible for Guruta (heaviness) in whole body, pain in all joints and bones, etc.
In Ayurved, acharyas have mentioned various therapeutic and parasurgical procedures, vatahara yogas to manage Sandhigata Vata. Parasurgical proceedures like Agnikarma, etc. are practiced in such condition as they are easy, provide quick relief from symptoms and have no complications.
Agnikarma is indicated in vata-kaphaj disorders. Agnikarma is effective, powerful and useful in diseases which are not amenable to Aoushadha , Shastra and kshara. It gives no room for the diseases to reoccur. It can be done to the skin, muscles, veins, tendons, joints and bones.
For Agnikarma different types of materials are used as they each show their unique effect on particular diseases. Pippali, ajashakrud, godant, shar, shalaka, jambavostha, lohadi dhatu, khoudra, guda, sneha, are advised to use for agnikarma. Jambavostha, suchi, shalaka, ghrit, madhu, madhuchista, tail, vasa, hema (gold), tamra (copper), rupya (silver), etc are also used.
So my topic is to compare and to evaluate the efficacy of Agnikarma with Tamra shalaka and Panchadhatu shalaka in management of Manya Sandhigata Vata with special reference to cervical Spondylosis which has been not done yet, hence this topic is selected. |