| CTRI Number |
CTRI/2020/09/027890 [Registered on: 18/09/2020] Trial Registered Prospectively |
| Last Modified On: |
16/09/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Management of Cervical Spondylosis through Ayurveda |
|
Scientific Title of Study
|
Comparative Assessment of Kukkutanda Pinda Sweda and Patra Pinda Sweda in the Management of Manyastambha (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 |
Dr Vivek Kumar Verma |
| Designation |
PG Scholar |
| Affiliation |
Datta Meghe Institute of Medical Sciences |
| Address |
Department Of Panchakarma Mahatma Gandhi Ayurveda College Hospital and Research Centre Salod(H), Wardha.
MAHARASTRA
442001 India
Department of Panchakarma Mahatma Gandhi Ayurveda College Hospital and Research Centre Salod(H), Wardha.
MAHARASTRA
442001 India
Wardha
MAHARASHTRA
442001
India |
| Phone |
8982175017 |
| Fax |
|
| Email |
vivekayupanch@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shweta Parwe |
| Designation |
Professor and HOD Panchakarma |
| Affiliation |
Datta Meghe Institute of Medical Sciences(Deemed University) |
| Address |
Department of Panchakarma Mahatma Gandhi Ayurveda College Hospital and Research Centre Salod(H), Wardha.
MAHARASTRA
442001 India
Department of Panchakarma Mahatma Gandhi Ayurveda College Hospital and Research Centre Salod(H), Wardha.
MAHARASTRA
442001 India
Wardha
MAHARASHTRA
442001
India |
| Phone |
9403142270 |
| Fax |
|
| Email |
drshwetaparve@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shweta Parwe |
| Designation |
Professor and HOD Panchakarma |
| Affiliation |
Datta Meghe institute of Medical Sciences(Deemed University) |
| Address |
Department of Panchakarma Mahatma Gandhi Ayurveda College Hospital and Research Centre Salod(H), Wardha.
MAHARASTRA
442001 India
Department of Panchakarma Mahatma Gandhi Ayurveda College Hospital and Research Centre Salod(H), Wardha.
MAHARASTRA
442001 India
Wardha
MAHARASHTRA
442001
India |
| Phone |
9403142270 |
| Fax |
|
| Email |
drshwetaparve@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Panchakarma, Mahatma Gandhi Ayurveda College Hospital and Research
Centre, Salod(H), Wardha |
|
|
Primary Sponsor
|
| Name |
Dr Vivek Kumar Verma |
| Address |
Department of Panchakarma, Mahatma Gandhi Ayurveda College
Hospital and Research Centre, Salod (H), Wardha |
| Type of Sponsor |
Other [[Self]] |
|
|
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 Vivek Kumar Verma |
Mahatma Gandhi Ayurved College Hospital and Research Center Salod (H) Wardha |
OPD and IPD of
Department of
Panchakarma Room No 40
Wardha
MAHARASHTRA |
8982175017
vivekayupanch@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Datta Meghe Institute of Medical Sciences |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M478||Other spondylosis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Group 2 Patra Pinda sweda |
Patra Pinda sweda
dose: 50ml Tila tail for frying leaves and Local manyapradesh abhyang and heating potali Nirgundi(vitex negundo)Leaves 25 gram, Erand(Ricinus communis) Leaves 25 gram, Chincha(Tarmindus indica) Leaves 25 gram, Dhatura(Datura metel) Leaves 5 gram, Shigru(moringa oleifera) Leaves 5 gram, Arka(Calotropis procera) Leaves 5 gram, Grated coconut 50g, Lemon 2, , Saindhav ,Rasnachurna each 5 gram
Frequency: once a day 10 am daily for 15-20 minutes Route of Administration:Skin local apply Nape of Neck Duration of Therapy: 7 days
|
| Comparator Agent |
GROUP 1 kukkutanda Pinda sweda |
kukkutanda Pinda Sweda
Dose:Tila tail 50 ml-for abhyanga, 4 Kukkutanda (eggs), Saindhavalavana 10 gms
Frequency: once a day 10 am daily for 15-20 minutes
Route of Administration:Skin local apply Nape of Neck
Duration of Therapy: 7 days
|
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
Patients of either genders with signs and symptoms of Manyastambha (Cervical Spondylosis)
Patients with in the Age group of 25 to 45 years
Patients fit for Swedana procedure
Patients ready to give inform consent and abide instruction
|
|
| ExclusionCriteria |
| Details |
Diseases such as Spinal stenosis “Cervical region Ankylosing hyperostosis, Kissing spine,
Traumatic spondylopathy,Fatigue fracture of cervical vertebra, Tubercular spine
Brucella spondylitis,Enterobacterial spondylosis,Neuropathic spondylopathy,Collapsed vertebra ,Gouty arthritis,Rheumatoid arthritis,
Congenital torticollis,History of any surgical diagnostic intervention with reference to the affected joints .Patient having Pregnancy will also exclude from the study.Patient having fatal complications of serious illness will exclude
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reduce the symptom of Manyastambha(Cervicalspondylosis) |
7 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1 to study the effect of kukkutanda pinda sweda in the management of manyastambha(cervical spondylosis)
2 to study the effect of patra pinda sweda in the managment of manyastmbha(cervical spondylosis)
3 to compare the effect of kukkutanda pinda sweda with patra pinda sweda in the management of manyastambha(cervical spondylosis) |
7 days |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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 |
|
Date of First Enrollment (India)
|
19/09/2020 |
| 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)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Patients will be recruited from inclusion criteria and study the effect of kukkutanda pinda sweda and patra pinda sweda in the management of manyastambha (cervical spondylosis) to study the effect of kukkutanda pinda sweda in the management of manyastambha (cervical spondylosis) to study the effect of patra pinda sweda in the management of manyastambha (cervical spondylosis) to compare the effect of kukkutanda pinda sweda with patra pinda sweda sweda in the management of manyastambha (cervical spondylosis) |