| CTRI Number |
CTRI/2024/11/076969 [Registered on: 18/11/2024] Trial Registered Prospectively |
| Last Modified On: |
14/11/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
TO EVALUATE THE EFFICACY OF VIDDHAAGNI KARMA USING HOT NEEDLING TECHNIQUE IN THE MANAGEMENT OF MANYASTAMBHA (CERVICAL SPONDYLOSIS) |
|
Scientific Title of Study
|
A Randomized Control Clinical Trial To Study The Efficacy Of Viddhagni Karma In The Management Of Manyasthambha W.S.R To Cervical Spondylosis |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Harshala Avinash Patil |
| Designation |
PG Scholar MS Shalyatantra |
| Affiliation |
MES Ayurved Mahavidyalaya |
| Address |
Second floor, Shalyatantra department, PG Section, MES Ayurved Mahavidyalaya, Ghanekhunt Lote, Khed,Ratnagiri
MAHARASHTRA
415722
Ratnagiri
MAHARASHTRA
415722
India |
| Phone |
9834932349 |
| Fax |
|
| Email |
harshajan141998@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Yogesh Borase |
| Designation |
HOD & Professor MS Shalyatantra |
| Affiliation |
MES Ayurved Mahavidyalaya |
| Address |
Second floor, Shalyatantra department, PG Section, MES Ayurved Mahavidyalaya, Ghanekhunt Lote, Khed,Ratnagiri
MAHARASHTRA
415722
Ratnagiri
MAHARASHTRA
415722
India |
| Phone |
8329008455 |
| Fax |
|
| Email |
dryogeshborase@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Harshala Avinash Patil |
| Designation |
PG Scholar MS Shalyatantra |
| Affiliation |
MES Ayurved Mahavidyalaya |
| Address |
Second floor, Shalyatantra department, PG Section, MES Ayurved Mahavidyalaya, Ghanekhunt Lote, Khed,Ratnagiri
MAHARASHTRA
415722
Ratnagiri
MAHARASHTRA
415722
India |
| Phone |
09834932349 |
| Fax |
|
| Email |
harshajan141998@gmail.com |
|
|
Source of Monetary or Material Support
|
| MES Ayurved Mahavidyalaya & attached Parshuram Hospital & Research Center,
Ghanekhunt Lote, Khed, Ratnagiri, Maharashtra, India-415722. |
|
|
Primary Sponsor
|
| Name |
Dr Harshala Avinash Patil |
| Address |
MES Ayurved Mahavidyalaya , Ghanekhunt Lote ,Khed, Ratnagiri, Maharashtra, India- 415722 |
| 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 Harshala Avinash Patil |
MES Parshuram Hospital |
Department of Shalyatantra ,OPD No 1, Parshuram Hospital,
Ghanekhunt Lote,Khed.
Ratnagiri
MAHARASHTRA |
9834932349
harshajan141998@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| MES Ayurved mahavidyalaya ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:M479||Spondylosis, unspecified. Ayurveda Condition: MANYASTAMBAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Trayodashanga Guggulu, Reference: Bhaishajya Ratnavali Vatvyadhiadhikar, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 28 Days, anupAna/sahapAna: Yes(details: -koshnajala), Additional Information: - | | 2 | Intervention Arm | Procedure | - | Viddhaagni Karma | (Procedure Reference: Sushrut sutrasthan 5, sushrut sutrasthan 12, Procedure details: Viddhaagni Karma will be done using hot needling technique on 1st ,7th ,14th Day with follow up on 7th,14th,21st,28th Day)
|
|
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
patients of manyasthambha |
|
| ExclusionCriteria |
| Details |
1.Patients having age less than 30 yrs and more than 60 years irrespective of gender.
2. Skin diseases and localized ulceration.
3. History of injury, fracture, surgery of spine and cervical spondylosis.
4. K/C/O – DM, HTN, IHD, HIV & HbsAg
5. Patients on anticoagulant medications.
6. Patients undergoing physiotherapy treatment. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
1) The effect of Viddhaagni Karma
in the management of Manyastambha (Cervical Spondylosis.)
2) Changes in clinical features of patients of Manyasthambha |
28 days study with follow up on 7th, 14th, 21st, 28th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Detail Study about Manyastambha from ayurvedic and
modern texts.
2. To evaluate the methodology of Viddhaagni karma.
3. Literature review of Agnikarma & Viddhakarma |
18 months study with 28 days of study on each patient with follow up on 7th, 14th, 21st, 28th day |
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
25/11/2024 |
| 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="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Clinical Study Report
- Who will be able to view these files?
Response - Researchers who provide a methodologically sound proposal.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [harshajan141998@gmail.com].
- For how long will this data be available start date provided 01-01-2026 and end date provided 01-01-2035?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
Title : Randomized controlled clinical trial to evaluate the efficacy of viddhaagni karma using hot needling technique in the management of manyasthambha WSR to cervical spondylosis Null hypothesis H0 : Viddhaagnikarma using hot needling technique is not effective in the managemnet of manyasthambha. Alternative hypothesis H1: Viddhaagni karma using hot needling technique is effective in the managemnt of manyasthambha . Study Design :simple randomized controlled clinical trial Inclusive criteria: patients having age group 30 to 60 yrs irrespective of gender. , patients with clinical features of manyathambha. exclusive criteria : patients less than 30 yrs and above 60 yrs ,skin diseases and localized ulceration., history of injury, fracture, surgery of spine and cervical spondylosis.,K/C/O DM HTN IHD HIV HBSAG .,Patients on anticoagulant medications , patients undergoing physiotherapy treatment. sample size: total 60 (30 each group) patients coming in opd & ipd of shalyatantra department of our hospital with complaints of manyasthambha (cervical spondylosis). simple randomized sampling (lottery method) group A viddhaagni karma with hot needling technique group B TAB Trayodashang guggulu total duration of study 28 days mode of administration : local route follow upp on 7, 14, 21, 28 day assessment criteria objective: neck pain(VAS scale) , goniometer scale readings for angle of flexion and extension of neck subjective :neck stiffness, tingling sensation in upper limb , headache , giddiness, neck movement result : will be drawn as per assessment criteria and statistical analysis |