| CTRI Number |
CTRI/2025/03/081724 [Registered on: 06/03/2025] Trial Registered Prospectively |
| Last Modified On: |
15/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
effect of dashamoolyadi kwatha nasapanam (administration through nose) in cervical spondylosis. |
|
Scientific Title of Study
|
effect of dashamoolyadi kwatha nasapanam in 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 Pooja Ravan Gaikwad |
| Designation |
PG Scholar Department of Panchakarma |
| Affiliation |
Government Ayurveda College Thiruvananthapuram |
| Address |
Department of Panchakarma Government Ayurveda college Thiruvananthapuram Government Ayurveda Panchakarma Hospital Poojappura kerala
Kerala, India
Thiruvananthapuram
KERALA
695009
India |
| Phone |
8208490868 |
| Fax |
|
| Email |
pooja.r.gaikwad001@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Pooja Ravan Gaikwad |
| Designation |
PG Scholar Department of Panchakarma |
| Affiliation |
Government Ayurveda College Thiruvananthapuram |
| Address |
Department of Panchakarma Government Ayurveda college Thiruvananthapuram Government Ayurveda Panchakarma Hospital Poojappura kerala
Kerala, India
Thiruvananthapuram
KERALA
695009
India |
| Phone |
8208490868 |
| Fax |
|
| Email |
pooja.r.gaikwad001@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ambili Krishna |
| Designation |
Assistant professor |
| Affiliation |
Government Ayurveda College Thiruvananthapuram |
| Address |
Department of Panchakarma Government Ayurveda college Thiruvananthapuram Government Ayurveda Panchakarma Hospital Poojappura kerala
Kerala, India
Thiruvananthapuram
KERALA
695012
India |
| Phone |
9847827220 |
| Fax |
|
| Email |
dr.ambilikrishna@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government ayurveda college and hospital Thiruvananthapuram |
|
|
Primary Sponsor
|
| Name |
Dr Pooja Ravan Gaikwad |
| Address |
Department of Panchakarma Government ayurveda College Thiruvananthapuram government Ayurveda Panchakarma Hospital Poojappura 695012 |
| 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 Pooja Ravan Gaikwad |
Government ayurveda panchakarma hospital poojappura Thiruvananthapuram |
Department of panchakarma op no.1 government ayurveda panchakarma hospital poojappura Thiruvananthapuram Kerala 695012
Thiruvananthapuram
KERALA |
8208490868
pooja.r.gaikwad001@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee (IEC) govt ayurveda college Thiruvananthapuram kerala |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:M478||Other spondylosis. Ayurveda Condition: VATAVYADHIH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | pratimarSaH, प्रतिमर्श | (Procedure Reference: Sushruta samhita videha commentry , Procedure details: Poorva Karma: This includes preparation of Kashaya as mentioned in Bhaishajya
Ratnavali. Procedure will be done in nirama avastha of the disease. Sterilization of Nasapanam
yantra. Before doing Nasapanam patient is strictly advised to take food. Then, patient is taken
to a comfortable room which is without dust, extreme breeze & sunlight. Bahyasnehana with
tila taila in the form of Mrudu Abhyanga is done to shiras first & then over Gala, Kapola,
Lalata & Karna. After Snehana, mild Swedana is done to the part of the body above the
shoulders. Care of the eyes should be taken with closing the patient’s eyes with a band of
cloth.
Pradhana Karma: Once the Poorva Karma is over patient is made to sit comfortably on a
chair. (As there is no such specifications seen in classic about the position for Nasapanam, as
the procedure Nasapanam is considered to be followed as Nasyavat.) For Nasya It is been
explained in the classics that the position of head should be little lowered & on the same time
legs should be raised little. Head of the patient is then highly elevated & with the help of leftthumb patient’s nose raised simultaneously with the right hand, the Dashamoolyadi Kwatha(dashamoola,bala,masha) is
poured into the nostril (24 ml) at a stretch with the constant pressure over the bulb. The same
procedure should be repeated for other nostril also. During the procedure patients are asked to
swallow the contents as much as possible.
Paschat Karma: Gandoosha followed by Nasapanam. The patients advised to take
sukhoshna jala & laghu ahara. Patients are strictly advised to avoid sheeta jala snana &
Sheeta Jala Pana during the whole course.
Participants asked to follow the regimen prior to Nasya Karma.)
|
|
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Participants of age between 30-60 years
Participants satisfying the criteria as per Oswestry Disability Index For Neck Pain
Participants with known case of cervical spondylosis |
|
| ExclusionCriteria |
| Details |
Participants with recent history of spine injury
Participants with uncontrolled diabetes mellitus and hypertension
Participants contraindicated for Nasya |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Outcome measures are evaluated by comparing the pre and post measurements in
VAS Scale and Oswestry disability index score |
0th day
8th day
21st day |
|
|
Secondary Outcome
|
|
|
Target Sample Size
|
Total Sample Size="23"
Sample Size from India="23"
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)
|
11/03/2025 |
| 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
|
Cervical spondylosis is degenerative osteoarthritis of cervical spine. It is characterised by
degeneration of the intervertebral disc and osteophyte formation. It is a chronic degenerative
condition of cervical spine. Now a days, it encountered in middle aged group due to sedentary
lifestyle, continues sitting jobs and computer work. Cervical spondylosis is considered a natural
process of aging with a 95% prevalence by age 65 years. Most people remain asymptomatic
but can present with neck pain, as well as progress to cervical radiculopathy.
In ayurveda cervical spondylosis is clinically compared with Vishwachi, Apabahuka or
manyastambha. Nasapanam is nasal administration of internal medicine in larger dose.
Chakradatta, Bhav Prakash mentioned Nasapanam in vata vyadhi adhyay. According to
Ayurveda cervical spondylosis is a vatavyadhi. In which Dashamoolyadi Kwatha is vatshamak
in nature. Dashamoola gana is tridoshasamak, shothahar. Bala is balya., sangrahik, vatahar.
Masha is balya, brimhan,vrushya,vatanashak.
The data will be collected through visual analogue scale (VAS), Oswestry disability index for
neck pain. After collecting data detailed examination will be done. Nasapanam will be done in
dose of 1 pala (approximately 48 ml) 24 ml in each nostril for 7 days during 3.30-05.00 pm.
Changes in neck pain and shoulder pain will be analysed before the treatment, after treatment
on 8th day, follow up on 21st day. Depending upon distribution of variables, it will be analysed
using Wilcoxon’s signed rank test or paired t test. |