| CTRI Number |
CTRI/2025/09/094468 [Registered on: 09/09/2025] Trial Registered Prospectively |
| Last Modified On: |
27/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Diagnostic |
| Study Design |
Other |
|
Public Title of Study
|
Clinical Study on the Effect of Nasya Karma With and Without Greeva Pichu in the Management of Manyastambha (Cervical Spondylosis) |
|
Scientific Title of Study
|
Clinical evaluation of Nasya karma with and without greeva pichu in 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 Aishwary Srivastava |
| Designation |
PG Scholar Panchakarma |
| Affiliation |
Patanjali Bhartiya Ayurvigyan Evam Anusandhan Sansthan |
| Address |
Department of Panchakarma, Patanjali Bhartiya Ayurvigyan Evam Anusandhan Sansthan, Patanjali Yogpeeth Phase 1, Bahadrabad, Haridwar
Hardwar
UTTARANCHAL
249405
India |
| Phone |
9027721303 |
| Fax |
|
| Email |
9027721303asri@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ruchi Gupta |
| Designation |
Professor |
| Affiliation |
Patanjali Bhartiya Ayurvigyan Evam Anusandhan Sansthan |
| Address |
Department of Panchakarma, Patanjali Bhartiya Ayurvigyan Evam Anusandhan Sansthan, Patanjali Yogpeeth Phase 1, Bahadrabad, Haridwar
Hardwar
UTTARANCHAL
249405
India |
| Phone |
9469063888 |
| Fax |
|
| Email |
Ruchigupta1610@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ruchi Gupta |
| Designation |
Professor |
| Affiliation |
Patanjali Bhartiya Ayurvigyan Evam Anusandhan Sansthan |
| Address |
Department of Panchakarma, Patanjali Bhartiya Ayurvigyan Evam Anusandhan Sansthan, Patanjali Yogpeeth Phase 1, Bahadrabad, Haridwar
Hardwar
UTTARANCHAL
249405
India |
| Phone |
9469063888 |
| Fax |
|
| Email |
Ruchigupta1610@gmail.com |
|
|
Source of Monetary or Material Support
|
| Patanjali Bhartiya Ayurvigyan Evam Anusandhan Sansthan |
|
|
Primary Sponsor
|
| Name |
PATANJALI BHARTIYA AYURVIGYAN EVAM ANUSANDHAN SANSTHAN |
| Address |
PATANJALI BHARTIYA AYURVIGYAN EVAM ANUSANDHAN SANSTHAN, HARIDWAR, UTTARAKHAND, INDIA, 249405 |
| Type of Sponsor |
Private medical 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 |
| Aishwary Srivastava |
Patanjali Bhartiya Ayurvigyan Evam Anusandhan Sansthan |
OPD 4, Patanjali Bhartiya Ayurvigyan Evam Anusandhan Sansthan, Bahadrabad, Haridwar, India 249405
Hardwar
UTTARANCHAL |
9027721303
9027721303asri@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee Patanjali Ayurveda College |
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: Ashtanga hridayam sootra sthanam 20/17-20, 22/33, Procedure details: The intervention consists of Nasya Karma followed by Greeva Pichu using Mahanarayan oil, administered once daily for 7 consecutive days.
1. Nasya Karma
Medicine used: Mahanarayan oil.
Dose: 8 drops (approximately 0.4 mL) instilled in each nostril.
Procedure: The patient is positioned supine with the head slightly extended. A brief local massage of the face, forehead, & neck is performed prior to administration. Warm Mahanarayan oil (lukewarm temperature) is instilled drop by drop into each nostril. Gentle massage around the nose & forehead is done to facilitate absorption. The patient remains in position for 2–3 minutes.
Duration: Approximately 10–15 minutes per sitting.
2. Greeva Pichu
Medicine used: Mahanarayan oil.
Quantity: 500 mL per session.
Procedure: A sterile cotton pad is soaked in warm Mahanarayan oil & placed over the cervical region. The pad is kept warm by periodically reheating or replenishing the oil to maintain uniform temperature throughout the procedure.
Duration: 30–45 minutes per sitting.
3. Frequency & Course
Both procedures are performed in a single sitting, once daily.
Total duration of therapy: 7 days.)
| | 2 | Comparator Arm | Procedure | - | nasyam/ nastam, नस्यम्/ नस्तम् | (Procedure Reference: Ashtanga hridayam sootra sthanam 20/17-20, Procedure details: Nasya Karma
Medicine used: Mahanarayan oil.
Dose: 8 drops (approximately 0.4 mL) instilled in each nostril.
Procedure: The patient is positioned supine with the head slightly extended. A brief local massage of the face, forehead, & neck is performed prior to administration. Warm Mahanarayan oil (lukewarm temperature) is instilled drop by drop into each nostril. Gentle massage around the nose & forehead is done to facilitate absorption. The patient remains in position for 2–3 minutes.
Duration: Approximately 10–15 minutes per sitting.
procedure is performed in a single sitting, once daily.
Total duration of therapy: 7 days.
)
|
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
The patients between the age group of 18 to 60 years in either sex presenting with clinical features of Manyasthambh.
Diagnosed patients of Manyasthambh a on the basis of clinical symptoms and valid investigations.
Patient presented with clinical symptoms with or without radiological changes.
Willing to participate and able to provide signed informed consent.
Patients fit for Nasya Karma. |
|
| ExclusionCriteria |
| Details |
Cervical fracture and dislocation of cervical vertebrae.
Cervical compressive myelopathy.
Space occupying lesions of brain.
Post spinal surgical case.
Diagnosed Patients suffering from any acute diseases/any infectious disease/metabolic disease/chronic diseases (like rheumatoid arthritis, SLE, ankylosing Spondylosis).
Uncontrolled diabetes mellitus and hypertension.
Pregnant or lactating women.
Patient with evidence of malignancy. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
1 Pain
2 Greevastambha
3 Restrictions of movement
4 Greeva Hundanam
5 Tingling
6 Bhram
7 Greeva Sparsh Akshamatva
8 Greeva Shoth
9 Grip Weakness
|
7, 30 Days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Cluster of Wainner |
7, 30 days |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
20/09/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
20/09/2025 |
| 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)
Modification(s)
|
Open to Recruitment |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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 study is a randomised clinical trial for assessing Nasya with Mahanarayan oil in two groups one with greeva pichu with Mahanarayan oil and another without greeva pichu in patients of Manyastambha (cervical spondylosis). 60 randomly selected patients will be selected on OPD as well as IPD basis from department of panchakarma Patanjali Ayurveda Hospital, Patanjali Bhartiya Ayurvigyan Evum Anusandhan Sansthan Haridwar. Patient will be divided into 2 groups- 30 patients will be administered with Nasya and 30 patients will be administered with Nasya and Greeva Pichu for 7 days. Follow up will be taken after 1 month assessment to be done on the basis of subjective and objective parameters as discussed earlier. |