| CTRI Number |
CTRI/2025/09/094567 [Registered on: 11/09/2025] Trial Registered Prospectively |
| Last Modified On: |
10/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To assess the role of nasya in cervical spondylosis (manyastambha) |
|
Scientific Title of Study
|
RANDOMIZED COMPARATIVE EVALUATION OF NASYA KARMA WITH DASHMOOLA TAILAM AND KARPASASTHYADI TAILAM IN CERVICAL SPONDYLOSIS (MANYASTAMBHA) |
| 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 Abhishek Kumar Siddharth |
| Designation |
PG Scholar |
| Affiliation |
Himalayiya Ayurvedic PG Medical College and Hospital |
| Address |
OPD NO 11, Department of Panchakarma, Himalayiya Ayurvedic PG Medical College and Hospital, Fatehpur Tanda, Majri Grant via Doiwala, Dehradun, Uttaranchal, 248140
Dehradun
UTTARANCHAL
248140
India |
| Phone |
9990006760 |
| Fax |
|
| Email |
drabhisheksiddharth@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Arvind Gupta |
| Designation |
Professor |
| Affiliation |
Himalayiya Ayurvedic PG Medical College and Hospital |
| Address |
OPD NO 11, Department of Panchakarma, Himalayiya Ayurvedic PG Medical College and Hospital, Fatehpur Tanda, Majri Grant via Doiwala, Dehradun, Uttaranchal, 248140
Dehradun
UTTARANCHAL
248140
India |
| Phone |
7895624474 |
| Fax |
|
| Email |
arvindguptapk@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Arvind Gupta |
| Designation |
Professor |
| Affiliation |
Himalayiya Ayurvedic PG Medical College and Hospital |
| Address |
OPD NO 11, Department of Panchakarma, Himalayiya Ayurvedic PG Medical College and Hospital, Fatehpur Tanda, Majri Grant via Doiwala, Dehradun, Uttaranchal, 248140
UTTARANCHAL
248140
India |
| Phone |
7895624474 |
| Fax |
|
| Email |
arvindguptapk@gmail.com |
|
|
Source of Monetary or Material Support
|
| Himalayiya Ayurvedic PG Medical College and Hospital, Fatehpur Tanda, Majri Grant via Doiwala, Dehradun, Uttaranchal, 248140 |
|
|
Primary Sponsor
|
| Name |
Dr Abhishek Kumar Siddharth |
| Address |
Department of Panchakarma, Himalayiya Ayurvedic PG Medical College and Hospital, Fatehpur Tanda, Majri Grant via Doiwala, Dehradun, Uttaranchal, 248140 |
| 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 Abhishek Kumar Siddharth |
Himalayiya Ayurvedic PG Medical College and Hospital |
OPD NO 11, Department of Panchakarma, HAMC
Dehradun
UTTARANCHAL |
9990006760
drabhisheksiddharth@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Minutes of Institutional Ethical Committee |
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 | Intervention Arm | Procedure | - | nasyam/ nastam, नस्यम्/ नस्तम् | (Procedure Reference: Ashtang Hridayam Sutrasthan 20/13-16, Procedure details: Group A: Dashmoola Tailam Nasya. Group B: Karpasasthyadi Tailam Nasya.
Poorva karma-Abhyanga of face, neck, shoulder, head, nasal region with Murchhita Tila Tailam for 10-20 minutes followed by Nadi swedana with dashmool kwath
Pradhan karma - Nasya with Dashmool tailam /Karpasasthyadi tailam(416drops in increasing order)
Paschat Karma - Dhoomapanam with HaridraVarti, Kavala / Gandusha with warm water)
(1) Medicine Name: Dashmoola Tailam , Reference: Bhaishajya ratnavali Shiroroga, Route: Nasal, Dosage Form: Bindu/ Drops/ Spray (Karna/ Nasa/ Netra/ Mukha), Dose: 16(drops), Frequency: od, Duration: 7 Days(2) Medicine Name: Karpasasthyadi Tailam , Reference: Sahastrayogam Taila Prakarana, Route: Nasal, Dosage Form: Bindu/ Drops/ Spray (Karna/ Nasa/ Netra/ Mukha), Dose: 16(drops), Frequency: od, Duration: 7 Days |
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1 Patients with sign and symptoms of Cervical Spondylosis (Manyastambha)
2 Patients between the age group of 20-60 years
3 Patients irrespective of gender.
4 Patients fit for Nasya Karma
5 Patient with duration of illness of 1-5 years. |
|
| ExclusionCriteria |
| Details |
1 Patients with symptoms of traumatic origin
2 Any form of cervical spine surgery in the past
3 Pregnant and lactating mother and menstruating females.
4 Stenosis of spinal cord and myelopathy
5 Patients with uncontrolled diabetic and hypertensive history.
6 Acute and chronic infection of cervical spine. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Relief in Pain, Stiffness, Tenderness, Headache, Vertigo, Tingling sensation, Loss of sensation |
3 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Relief in sign and symptoms |
7 weeks |
|
|
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
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
24/09/2025 |
| 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 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
|
Cervical Spondylosis is a term that encompasses a wide range of
progressive degenerative changes that affect all the components of the cervical
spine.Cervical Spondylosis are now associated with disorders recorded in
ayurvedic texts such as Manyastambha Acharya Charak has included Manyastambha
under Eighty Vataja Nanatamaja Vyadhis. According to Sushruta, Vata Dosha &
Kapha dosha get aggravated & take Ashraya at Manya Pradesh, affecting the
Manya Siras (nerves of neck) causing Ruja (pain) and Stambha (stiffness or
difficulty in mobility) of the neck. As Vata and kapha is included in the pathogenesis
of manyastambha that’s why oil are being used as drugs for the treatment. Total
40 patients will be selected randomly and will be divided into two groups each
of 20 patients. Group A will be subjected to Dashmoola Tailam nasya and Group B
will be subjected to Karpasasthyadi Tailam Nasya. So here is an attempt to evaluate
the efficacy of these two under the topic “RANDOMIZED COMPARATIVE EVALUATION
OF NASYA KARMA WITH DASHMOOLA TAILAM AND KARPASASTHYADI TAILAM IN CERVICAL
SPONDYLOSIS (MANYASTAMBHA)” |