| CTRI Number |
CTRI/2025/07/092052 [Registered on: 30/07/2025] Trial Registered Prospectively |
| Last Modified On: |
23/02/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Managing Manyastambha (Cervical spondylosis) with Shrungaberadi Yoga Nasya and Gudadi Nasya:A Comparative Study. |
|
Scientific Title of Study
|
A Comparative Study to evaluate the effect of Shrungaberadi Yoga Nasya and Gudadi Nasya in the management of Manyastambha 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 Dishin M Vaghani |
| Designation |
Post Graduate Scholar |
| Affiliation |
Ramakrishna Ayurvedic medical college, Hospital and Research Centre |
| Address |
Department of Panchakarma of PG Studies, Ramakrishna Ayurvedic Medical college,Hospital and Research Centre, 54/2,Ramagondanahalli, Yelahanka, Bangalore.
Bangalore Rural
KARNATAKA
560064
India |
| Phone |
8095166802 |
| Fax |
|
| Email |
dishinv128@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rashmi R. |
| Designation |
HOD and Professor |
| Affiliation |
Ramakrishna Ayurvedic medical college, Hospital and Research Centre |
| Address |
Department of Panchakarma of PG Studies,Ramakrishna Ayurvedic Medical College, Hospital and Research Centre,54/2,Ramagondanahalli, Yelahanka, Bangalore-560064
Bangalore Rural
KARNATAKA
560064
India |
| Phone |
9886716509 |
| Fax |
|
| Email |
ayurray@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Dishin M Vaghani |
| Designation |
Post Graduate Scholar |
| Affiliation |
Ramakrishna Ayurvedic medical college, Hospital and Research Centre |
| Address |
Department of Panchakarma of PG Studies,Ramakrishna Ayurvedic Medical College,Hospital and Research Centre. 54/2,Ramagondanahalli, Yelahanka, Bangalore.
Bangalore Rural
KARNATAKA
560064
India |
| Phone |
8095166802 |
| Fax |
|
| Email |
dishinv128@gmail.com |
|
|
Source of Monetary or Material Support
|
| Ramakrishna Ayurvedic medical college, Hospital and Research Centre, 54/2,Ramagondanahalli, Yelahanka, Bangalore-560064 |
|
|
Primary Sponsor
|
| Name |
Dr Dishin Vaghani |
| Address |
Ramakrishna Ayurvedic medical college,Hospital and Research Centre, Bangalore,54/2,Ramagondanahalli, Yelahanka,Bangalore-560064 |
| 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 Dishin M Vaghani |
Ramakrishna Ayurvedic medical college Hospital and Research Centre |
Department of Panchakarma in PG Studies, 54/2,Ramagondanahalli,Yelahanka,Bangalore,560064
Bangalore Rural
KARNATAKA |
8095166802
dishinv128@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ramakrishna Ayurvedic Medical College, Hospital and Research Centre Ethical Clearance Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:M472||Other spondylosis with radiculopathy. Ayurveda Condition: MANYASTAMBAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Gudadi Nasya , Reference: Shri Brahmasankar Mishra, Bhavaprakash of Shri bhavamishra, volume 1, 11th Edition:2007, Published by Chaukhambha Sanskrit Bhawan, Varanasi. Niganthu bhaga, ikshuvarga, verse no.28, page no. 796, Route: Nasal, Dosage Form: Bindu/ Drops (Karna/ Nasa/ Netra), Dose: 4(drops), Frequency: od, Bhaishajya Kal: Abhakta, Duration: 7 Days, anupAna/sahapAna: No, Additional Information: - | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Shrungaberadi yoga nasya , Reference: Sri Indradeva Tripathi. Edited by Sri Ganga Sahaya Pandeya. Gadanigraha of Sri Vaidya Sodhala with the vidyotini hindi commentory, part-2. Third edition:1994. Published by chaukhambha publication. Chapter-16th, vatarogadhikara, verse no. 216, Route: Nasal, Dosage Form: Bindu/ Drops (Karna/ Nasa/ Netra), Dose: 4(drops), Frequency: od, Bhaishajya Kal: Abhakta, Duration: 7 Days, anupAna/sahapAna: No, Additional Information: - |
|
|
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Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patient presenting with signs and symptoms of Manyastambha (Cervical spondylosis) like
neck pain, stiffness of neck. Radiating pain to arm (may or may not).
Patients of either sex aged between 18-60 years.
Irrespective of sex, religion, occupation, and economic status.
Patient indicated for Nasya. |
|
| ExclusionCriteria |
| Details |
Patients having associated conditions like Fibrosis, Rheumatoid Arthritis and
Ankylosing Spondylosis.
Patients with a history of traumatic injury to the cervical spine.
Patients having fatal complications of serious illness are excluded.
Patients showing Cervical Spondylosis features due to Fracture, Malignancy.
Pregnant ladies and Lactating mothers. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Change in Visual Analog Scale (VAS) score from baseline to end of treatment.
Clinical improvement in Greeva shoola, stambha, and akshepa as per classical Ayurvedic symptoms grading. |
Day 0,End of the Treatment day 7th,First follow-up on Day 14th,Seconf follow-up on Day 21st.
Clinical improvement in Greeva shoola, stambha, and akshepa as per classical Ayurvedic symptoms grading. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
Final Enrollment numbers achieved (Total)= "40"
Final Enrollment numbers achieved (India)="40" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
10/07/2026 |
| Date of Study Completion (India) |
01/01/2026 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="2"
Months="6"
Days="10" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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
|
This is a postgraduate academic clinical study conducted to compare the therapeutic efficacy of Shrungaberadi Yoga Nasya and Gudadi Nasya in the management of Manyastambha, with special reference to Cervical Spondylosis. Manyastambha is a Vata-dominant disorder characterized by stiffness and pain in the neck, often correlated with cervical spondylosis in modern medicine.
Two classical Ayurvedic Nasya formulations Shrungaberadi Yoga and Gudadi Yoga are administered as Avapeeda Nasya for a specified duration under standard Panchakarma protocols. The primary objective of the study is to assess and compare the reduction in symptoms such as neck pain, stiffness, and restricted movement using Neck Disability Index (NDI) and Visual Analog Scale (VAS).
Participants will be randomly allocated into two groups. The treatment will be given for 7 days, followed by a follow-up on 14th day. The outcome will help evaluate the comparative efficacy of these two classical formulations in the management of Manyastambha and explore their role in improving quality of life in patients with cervical spondylosis.
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