| CTRI Number |
CTRI/2025/03/082151 [Registered on: 11/03/2025] Trial Registered Prospectively |
| Last Modified On: |
07/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
efficacy of Pippalisunthyadi nasya and Gudadi nasya in the management of neck pain and stiffness |
|
Scientific Title of Study
|
A Randomized comparative clinical trial to evaluate the efficacy of Pippalisunthyadi avpeed nasya and Gudadi avpeed nasya in the management of 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 |
Vd Preeti Vijayrao Choudhari |
| Designation |
PG Scholar |
| Affiliation |
Pdeas college of ayurved and research center sector no 25 nigadi pune maharashtra |
| Address |
Pdeas college of ayurved and research center third floor panchkarma department sector no 25 nigadi pune maharashtra
Pune
MAHARASHTRA
411044
India |
| Phone |
9370504813 |
| Fax |
|
| Email |
preetichoudhari67@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Vd Varsha Sane |
| Designation |
Professor |
| Affiliation |
Pdeas college of ayurved and research center sector no 25 nigadi pune maharashtra |
| Address |
Pdeas college of ayurved and research center third floor panchkarma department sector no 25 nigadi pune maharashtra
Pune
MAHARASHTRA
411044
India |
| Phone |
9923800634 |
| Fax |
|
| Email |
varsha.kale80@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Vd Preeti Vijayrao Choudhari |
| Designation |
PG scholar |
| Affiliation |
Pdeas college of ayurved and research center sector no 25 nigadi pune maharashtra |
| Address |
Pdeas college of ayurved and research center third floor panchkarma department sector no 25 nigadi pune maharashtra
Pune
MAHARASHTRA
411044
India |
| Phone |
9370504813 |
| Fax |
|
| Email |
preetichoudhari67@gmail.com |
|
|
Source of Monetary or Material Support
|
| Pdeas college of ayurved and research center nigadi pune 411044 |
|
|
Primary Sponsor
|
| Name |
PDEAS COLLEGE OF AYURVED AND RESEARCH CENTRE NIGADI PUNE |
| Address |
Pdeas college of ayurved and research center sector no 25 nigadi pradhikaran pune 411044 |
| 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 |
| Dr Preeti Vijayrao Choudhari |
Ayurved Rugnalay And Snowbell Multispecialty Hospital |
Panchkarma department 1st floor OPD no 216 nigadi pradhikaran Pune Maharashtra 411044
Pune
MAHARASHTRA |
9370504813
preetichoudhari67@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| PDEA COLLEGE Institutional Ethical 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 | Comparator Arm | Procedure | - | nasyam/ nastam, नस्यम्/ नस्तम् | (Procedure Reference: Ashtang Hrudya Sutrasthan 20/17-22, Procedure details: 30 min including purva, pradhan and pachhat karma )
(1) Medicine Name: gud, sunthi churn, water, Reference: Tripathi B. Sharangdhar Samhita of Pandit Sharangdhar Acharya. Uttarkhanda 8/18-19. Varanasi: Chaukhamba Surbharti Pratisthana; 2017. p. 246., Route: Nasal, Dosage Form: Swaras/ Juice, Dose: 4(drops), Frequency: od, Duration: 7 Days | | 2 | Intervention Arm | Procedure | - | nasyam/ nastam, नस्यम्/ नस्तम् | (Procedure Reference: Ashtang Hrudya Sutrasthan 20/17-22., Procedure details: 30 min including purva, pradhan and paschhat karma)
(1) Medicine Name: pippali churn, saindhav, sunthi churn, gud, water, Reference: Tripathi B. Sharangdhar Samhita of Pandit Sharangdhar Acharya. Uttarkhanda 8/18-19. Varanasi: Chaukhamba Surbharti Pratisthana; 2017. p. 246., Route: Nasal, Dosage Form: Swaras/ Juice, Dose: 4(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 pratyatma lakshan of manyastmbha - shool(neck pain), stambha(neck stiffness)
2.(Arha)Indicates for nasya karma
3. Patient irrespective of caste, religion, economic status. |
|
| ExclusionCriteria |
| Details |
1.Patients presenting with fracture or dislocation of cervical vertebrae and intervertebral disc.
2.Patients with accidental cases.
3.Known case of congenital anomalies of spine.
4.patients contraindicative(anarha) for nasya |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To determine efficacy of Pippalisunthyadi avpeeed nasya and Gudadi avpeed nasya in the management of Manyastambh after 7 Days. |
To determine efficacy of Pippalisunthyadi avpeeed nasya and Gudadi avpeed nasya in the management of Manyastambh after 7 Days. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To determine efficacy of pippalyadi avpeed nasya & gudadi avpeed nasya within 7 days |
To determine efficacy of pippalyadi avpeed nasya & gudadi avpeed nasya within 7 days |
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
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)
|
07/04/2025 |
| 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="0"
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
|
Manyastambha is a relatively common condition that affects a large portion of the population, In our modern, competitive environment, sedentary lifestyles, prolonged travel, and changes in dietary habits have become increasingly prevalent lifestyle shifts can significantly impact long-term health, particularly affecting the musculoskeletal system and impeding everyday activities.Acharya Sushruta has described that sleeping during the day, leaning or sleeping on uneven surfaces, constantly looking up or down, and overstretching the neck can vitiate the Vata and Kapha doshas. These doshas then take residence in the neck region (manyapradesha), causing pain (ruja) and stiffness (stambha). In Ayurvedic practice, Nasya Karma stands out as a significant therapeutic procedure, particularly noted for its efficacy in treating Manyastambha. Nasal passages are regarded as the gateway to the head, through which medicinal substances spread, pacifying aggravated doshas. This nasal therapy plays a pivotal role in managing disorders of the Urdhwajatrugata pradesha.
This present study designed to evaluate efficacy of nasya using two different medicated swaras preparation that is avpeed nasya of pippalyadi and gudadi medicated swaras.. |