| CTRI Number |
CTRI/2025/06/088346 [Registered on: 05/06/2025] Trial Registered Prospectively |
| Last Modified On: |
05/06/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effect of Valuka Pinda Sweda in Manyastambha (Cervical Spondylosis) |
|
Scientific Title of Study
|
A randomized controlled clinical trial to study the adjuvant effect of valuka pinda sweda with isometric neck exercises in manyastambha with special reference 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 Sneha Dhananjay Nikam |
| Designation |
Post Graduate Student |
| Affiliation |
SMBT Ayurved College and Hospital |
| Address |
Department of Panchkarma SMBT Ayurved College and Hospital Nandi hills Dhamangaon Igatpuri Nashik MAHARASHTRA 422403 India
Nashik
MAHARASHTRA
422403
India |
| Phone |
9921040014 |
| Fax |
|
| Email |
sdnikam2017@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Pramod Sakharam Mandalkar |
| Designation |
Proffesor |
| Affiliation |
SMBT Ayurved College and Hospital |
| Address |
Department of Panchkarma SMBT Ayurved College and Hospital Nandi hills Dhamangaon Igatpuri Nashik MAHARASHTRA 422403 India
Nashik
MAHARASHTRA
422403
India |
| Phone |
9604633832 |
| Fax |
|
| Email |
vdpramod31@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sneha Dhananjay Nikam |
| Designation |
Post graduate student |
| Affiliation |
SMBT Ayurved College and Hospital |
| Address |
Department of Panchkarma SMBT Ayurved College and Hospital Nandi hills Dhamangaon Igatpuri Nashik MAHARASHTRA 422403 India
Nashik
MAHARASHTRA
422403
India |
| Phone |
9921040014 |
| Fax |
|
| Email |
sdnikam2017@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Panchkarma SMBT Ayurved College and Hospital Nandi hills Dhamangaon Igatpuri Nashik MAHARASHTRA 422403 India |
|
|
Primary Sponsor
|
| Name |
Dr Sneha Nikam |
| Address |
Department of Panchkarma SMBT Ayurved College and Hospital Nandi hills Dhamangaon Igatpuri Nashik MAHARASHTRA 422403 India |
| Type of Sponsor |
Other [Private Ayurved College] |
|
|
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 Sneha Nikam |
SMBT Ayurved College and Hospital |
OPD No 19 Department of Panchkarma SMBT Ayurved College and Hospital Nandi hills Dhamangaon Igatpuri Nashik MAHARASHTRA 422403 India
Nashik
MAHARASHTRA |
9921040014
sdnikam2017@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SMBT Ayurved College and Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:M478||Other spondylosis. Ayurveda Condition: MANYASTAMBAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm (Non Ayurveda) | | - | ISOMETRIC NECK EXERCISES | 1) Cervical flexion: Lean the neck slightly forward, place palm of both
hands on forehead and push the head towards the hands while resisting
the movement with hands.
2)Cervical extension: Keep the neck straight, put palm of both hands
behind the head, push the head backwards the hands while resisting the
movement with hands.
3) Right Lateral Flexion: Keep the neck straight, put palm of right hand on
right side of the head, push the head towards the hand to bring head
down to the right shoulder while pushing the hand vice versa.
4 )Left Lateral Flexion: Keep the neck straight, put palm of left hand on left
side of the head, push the head towards the hand to bring head down to
the left shoulder while pushing the hand vice versa.
5) Right Rotation: Put palm of right hand on right side of face, rotate the
head slightly to the right while resisting the movement with hand.
6 )Left Rotation: Put palm of left hand on left side of face, rotate the head
slightly to the left while resisting the movement with hand.
• 3 sets/day (morning,afternoon,evening).Each set consisted of 6
movements for 10s and repeating each 5 times with a 5 sec rest
between each of them. | | 2 | Intervention Arm | Procedure | - | svedanam, स्वेदनम् | (Procedure Reference: Dr Pramod Mandalkar Therapeutic Procedures of Panchakarma Minor Panchakarma Procedure Chapter 36 Pg No 164 Rudra Publication 2022, Procedure details: Before applying the heat,therapist should confirm the temp of
bolus by touching it on the dorsum of his hand.Initially heating the
bolus is more & then bolus is repeatedly but momentarily
touches the part till the heat in the bolus is lost considerably.When
temperature is become moderate then the bolus is allow to give
continue swedana by gently moving over joint.Bolus moves in
circular manner in clockwise & anticlockwise direction over joint
while in linear manner around joint.After sometime temp.of bolus
is tolerable then the bolus is placed over joint till the bolus loses its
temp completely .Swedana is continuedby taking another sand
bolus.This procedure is continued for 30-45 minutes to get
desirable effects)
|
|
|
|
Inclusion Criteria
|
| Age From |
35.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1)Patients having classical signs and symptoms of Manyastambha
like stiffness and pain in the neck region.
2) Patients fulfilling the diagnostic criteria.
3) Patient who will give consent & Fit for the procedure. |
|
| ExclusionCriteria |
| Details |
1)Patients with history of fracture or dislocated of cervical region.
2)Patients with Diabetes and Cardio vascular diseases, traumatic,
infective, neoplastic spine.
3) Known case of Congenital anomalies of spine.
4)Patients having automotive deformities like ankylosing
spondylitis, spinal cord abscess, Rheumatoid arthritis as well as
congenital structural disorder will be excluded.
5) Traumatic disorders like cervical strain, injuries to intervertebral
joints, ligaments and muscles, Fractures and ruptured disc.
6) Patients with other joints disorder which are not relates to Manyastambha will be excluded.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reduction in signs and symptoms of Manyastambha |
7 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Where the trial group stands in comparison with control group |
18 months |
|
|
Target Sample Size
|
Total Sample Size="76"
Sample Size from India="76"
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)
|
16/06/2025 |
| 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 - NO
|
|
Brief Summary
|
Manyastambha is one of the most important amongst the eighty types of nanatmajvyadhi.vatajvyadhi. In Manyastambha back of neck becomes stiff and rigid and the movements of neck are impaired. The main characteristic feature of Manyastambha are neck pain and stiffnessThe population based study from India shows prevalence of manyastambha is 5.23%it is one of the diseases which is painful and affects normal routine of life so there is need to find an alternative solution of this problem. Present study of randomised controlled trial will be carried out to study the adjuvant . Effect of valuka pinda sweda with isometric neck exercises in Manyastambha with special reference to cervical spondylosis for present study subjects between age group 35 to 70 will be taken irrespective of religion ,gender,socioeconomic status .sample size found 38 .Total 76 patients will be taken for study with 38 patient in group A(trial group) and 38 patients in group B (control group).valuka pinda sweda will be taken in Group A (trial group ) and isometric neck exercises in Group B (control group ) .procedure will be done with external application for 7 days .all sop will be followed .all the findings will be entered in case record form . Observations will be drawn before ,during and after treatment. Result will be drawn with the help of statical method. Discussion will be done on the basis statatical analysis and will be unbiased |