| CTRI Number |
CTRI/2025/04/084720 [Registered on: 15/04/2025] Trial Registered Prospectively |
| Last Modified On: |
11/04/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
This is a study conducted to know the efficacy of nasya with mashabaladi kwatha for the management of cervical spondylosis. |
|
Scientific Title of Study
|
A randomised controlled clinical study to evaluate the efficacy of nasya with mashabaladi kwatha in the management of manyasthambha |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Aishwarya Suresh Belle |
| Designation |
Post graduate resident |
| Affiliation |
Muniyal institute of ayurveda medical science, manipal |
| Address |
Out patient ward , department of panchakarma, ground floor, room no.3
Muniyal institute of ayurveda medical science
34-C, Shivalli, Industrial Area, Manipal, Karnataka 576104
Udupi
KARNATAKA
576104
India |
| Phone |
9483318796 |
| Fax |
|
| Email |
belleaishwarya@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DrGuruprasad G |
| Designation |
Professor |
| Affiliation |
Muniyal institute of ayurveda medical science manipal |
| Address |
Out patient ward , department of panchakarma, ground floor, room no.3
Muniyal institute of ayurveda medical science
34-C, Shivalli, Industrial Area, Manipal, Karnataka 576104
Udupi
KARNATAKA
576104
India |
| Phone |
9844632505 |
| Fax |
|
| Email |
shettydrguruprasad@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
DrGuruprasad G |
| Designation |
Professor |
| Affiliation |
Muniyal institute of ayurveda medical science manipal |
| Address |
Out patient ward , department of panchakarma, ground floor, room no.3
Muniyal institute of ayurveda medical science
34-C, Shivalli, Industrial Area, Manipal, Karnataka 576104
Udupi
KARNATAKA
576104
India |
| Phone |
9844632505 |
| Fax |
|
| Email |
shettydrguruprasad@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
| MUNIYAL INSTITUTE OF AYURVEDA MEDICAL SCIENCE AND RESEARCH CENTRE MANIPAL
34-C Shivalli, Industrial area
Manipal-Udupi
576104 |
|
|
Primary Sponsor
|
| Name |
Aishwarya Suresh Belle |
| Address |
Muniyal institute of ayurveda medical science
34-C, Shivalli, Industrial Area, Manipal, Karnataka 576104 |
| 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 Aishwarya Suresh Belle |
Muniyal institute of ayurveda medical science manipal |
Out patient department of panchakarma room no.3 ground floor,
Udupi
KARNATAKA |
9483318796
belleaishwarya@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| muniyal institute of ayurveda medical science manipal institutions 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 | Intervention Arm | Procedure | - | nasyam/ nastam, नस्यम्/ नस्तम् | (Procedure Reference: Gada nigraha, shri vaidya shodala with comentory of vidyotini kayachikitsa khanda 2, pg-459, chapter by sri indradeva tripathi, published by chaukambha oriental varanasi., Procedure details: Group A: 20 patients will be treated using Mashabaladi kwatha nasya.
Group B: 20 patients will be treated using Dashamoola kwatha nasya.
Therapeutic:
Group A:
Poorvakarma – Sthanika Abhyanga with Murchita tila taila & BashpaSveda with dashamoola kwatha.
Pradhanakarma – Mashabaladi kwatha nasya
Paschat karma – Kavala with Sukoshnajala and Dhoompana with Haridra Dhuma varti.
Group B:
Poorvakarma – Sthanika Abhyanga with Murchita tila taila and Bashapasveda with dashamoola kwatha
Pradhanakarma – Dashamooladi kwatha nasya
Paschat karma – Kavala with Sukoshnjala and Dhoomapana with Haridra Dhuma varti.
Posology: 6 drops each nostril in empty stomach)
(1) Medicine Name: Mashabaladi kwatha, Reference: Gada nigraha, shri vaidya shodala with comentory of vidyotini kayachikitsa khanda 2, pg-459, chapter by sri indradeva tripathi, published by chaukambha oriental varanasi., Route: Nasal, Dosage Form: Kwatha/Kashaya, Dose: 6(drops), Frequency: od, Duration: 7 Days | | 2 | Comparator Arm | Procedure | - | nasyam/ nastam, नस्यम्/ नस्तम् | (Procedure Reference: Gada nigraha, shri vaidya shodala with comentory of vidyotini kayachikitsa khanda 2, pg-459, chapter by sri indradeva tripathi, published by chaukambha oriental varanasi., Procedure details: Group A: 20 patients will be treated using Mashabaladi kwatha nasya.
Group B: 20 patients will be treated using Dashamoola kwatha nasya.
Therapeutic:
Group A:
Poorvakarma – Sthanika Abhyanga with Murchita tila taila & BashpaSveda with dashamoola kwatha.
Pradhanakarma – Mashabaladi kwatha nasya
Paschat karma – Kavala with Sukoshnajala and Dhoompana with Haridra Dhuma varti.
Group B:
Poorvakarma – Sthanika Abhyanga with Murchita tila taila and Bashapasveda with dashamoola kwatha
Pradhanakarma – Dashamooladi kwatha nasya
Paschat karma – Kavala with Sukoshnjala and Dhoomapana with Haridra Dhuma varti.
Posology: 6 drops each nostril in empty stomach)
(1) Medicine Name: Dashamoola kwatha, Reference: Bhavaprakasha of bhavamishra by Dr. b. sitaram, madhyama khnada, Vol 2, published by chaukambha orientalia, 2010 edition., Route: Nasal, Dosage Form: Kwatha/Kashaya, Dose: 6(drops), Frequency: od, Duration: 7 Days |
|
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Patients with classical symptoms of Manyastamba.
Patients of the age group between 30-70 years.
Patients of either gender irrespective of caste and religion.
Patients who are fit for narya. |
|
| ExclusionCriteria |
| Details |
Pregnant women and lactating mother.
Any disorder contraindicated for nasya.
Patient with congenital deformities of spine.
Some diseased condition like cervical radiculopathy |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
assessment of pain will be done
to reduce pain |
7th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Ro minimise the stiffness and restricted range of movement |
14days |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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)
|
22/04/2025 |
| 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="3"
Days="15" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
According to global burden of disease 2015, neck pain remain the leading cause of years lived with diasability and fourth leading cause of diasability adjusted life years. The prevalence of cervical spondylosis was 13.76% and cervical spondylosis is considered a natural process of aging with a 95% prevalence by age of 65 years. In the present era of modernisation, people are prone to numerous degenerative disease due to present day lifestyle, a great number of people are inclined to desk work and computer usage .manyasthambha is one among such disease where the stiffness of neck with severe pain is the classical symptom which hampers our day to day life.
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