| CTRI Number |
CTRI/2025/03/083428 [Registered on: 25/03/2025] Trial Registered Prospectively |
| Last Modified On: |
01/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A Randomized Clinical Study to compare the effect of Greeva Basti and Nasya Karma with Greeva Pichu and Nasya Karma in Cervical Spondylosis. |
|
Scientific Title of Study
|
A Randomized clinical study to compare the effect of Greeva Basti and Nasya Karma with Greeva Pichu and Nasya Karma in Cervical Spondylosis. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| 14 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Sai Chinmayee T |
| Designation |
PG Scholar |
| Affiliation |
Sri Kalabyraveshwaraswamy Ayurvedic Medical College Hospital and Research Center |
| Address |
Sri Kalabyraveshwaraswamy Ayurvedic Medical College Hospital and Research Center OPD 01 Pipeline road RPC Layout Vijayanagar Bangalore karnataka 560104 India PIPELINE ROAD RPC LAYOUT VIJAYANAGAR 2ND STAGE BENGALURU 560 104 Sri Kalabyraveshwaraswamy Ayurvedic Medical College Hospital and Research Center OPD 01 Pipeline road RPC Layout Vijayanagar Bangalore Karnataka 560104 Bangalore KARNATAKA 560104 India |
| Phone |
6238498998 |
| Fax |
|
| Email |
chinmayibhat02@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Vinay Kumar KN |
| Designation |
Professor and HOD |
| Affiliation |
Sri Kalabyraveshwaraswamy Ayurvedic Medical College Hospital and Research Center |
| Address |
Sri Kalabyraveshwaraswamy Ayurvedic Medical College Hospital and Research Center OPD 01 Pipeline road RPC Layout Vijayanagar Bangalore karnataka 560104 Sri Kalabyraveshwaraswamy Ayurvedic Medical College Hospital and Research Center OPD 01 Pipeline road RPC Layout Vijayanagar Bangalore Karnataka 560104 Bangalore KARNATAKA 560 104 India |
| Phone |
9845617690 |
| Fax |
|
| Email |
knv.gowda@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Vinay Kumar KN |
| Designation |
Professor and HOD |
| Affiliation |
Sri Kalabyraveshwaraswamy Ayurvedic Medical College Hospital and Research Center OPD 01 Pipeline road RPC Layout Vijayanagar Bangalore karnataka 560104 India |
| Address |
Sri Kalabyraveshwaraswamy Ayurvedic Medical College Hospital and Research Center OPD 01 Pipeline road RPC Layout Vijayanagar Bangalore karnataka 560104 India Sri Kalabyraveshwaraswamy Ayurvedic Medical College Hospital and Research Center OPD 01 Pipeline road RPC Layout Vijayanagar Bangalore karnataka 560104 India10 PIPELINE ROAD RPC LAYOUT VIJAYANAGAR 2ND STAGE BENGALURU 560 104 Bangalore KARNATAKA 560 104 India |
| Phone |
9845617690 |
| Fax |
|
| Email |
knv.gowda@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sri Kalabyraveshwaraswamy Ayurvedic Medical College Hospital and Research Center |
|
|
Primary Sponsor
|
| Name |
Dr SAI CHINMAYEE T |
| Address |
SRI KALABYRAVESHWARASWAMY AYURVEDIC MEDICAL COLLEGE HOSPITAL AND RESEARCH CENTRE 10 PIPELINE ROAD RPC LAYOUT VIJAYANAGAR 2ND STAGE BENGALURU 560 104 |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
|
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Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr KIRAN M GOUD |
Sri Kalabyraveshwaraswamy Ayurvedic Medical College Hospital and Research Center Bangalore |
OPD 01 Ground Floor Department of PG studies in Panchakarma Bangalore KARNATAKA |
9845109556
kiranmgoud@yahoo.co.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Sri Kalabyraveshwaraswamy Ayurvedic Medical College Hospital and Research Center |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:M479||Spondylosis, unspecified. Ayurveda Condition: CERVICAL SPONDYLOSIS, (2) ICD-10 Condition:M479||Spondylosis, unspecified. Ayurveda Condition: VISVACI, |
|
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Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | GREEVA BASTI AND NASYA KARMA | (Procedure Reference: ASHTANGA HRUDAYA SUTHRA 20, SUSHRUTHA SUTHRA 1, ASHTANGA SUTHRA 22, CHARAKA SIDDI 2, Procedure details: GREEVA BASTI-Moorchita Tila Taila is indirectly heated in water bath and is poured into frame by using cotton swab.When the heated oil gets cooled down, it is taken out of the frame with help of cotton swab. Fresh warm oil is then poured into frame. This is repeated for 30 minutes duration. After 30 minutes, complete oil is taken out from frame with a cotton swab. NASYA KARMA - The patient is made to lie down in supine position Nasya karma will be done by instilling Eight Bindu pramana of Prasar) (1) Medicine Name: MOORCHITA TILA TAILA, Reference: BHAISHAJYA RATNAVALI JWARA ADHIKARA, Route: Topical, Dosage Form: Taila, Dose: 200(ml), Frequency: od, Duration: 7 Days(2) Medicine Name: PRASARINYADI TAILA, Reference: YOGA RATNAKARA VATAVYADHI CHIKITHSA, Route: Nasal, Dosage Form: Taila, Dose: 8(drops), Frequency: od, Duration: 7 Days | | 2 | Comparator Arm | Procedure | - | nasyam/ nastam, नस्यम्/ नस्तम् | (Procedure Reference: Ashtanga hrudaya 22, Procedure details: The patient is made to lie down in supine position Nasya karma will be done by instilling Eight Bindu pramana of Prasarini Taila in avichinna dhara to each nostril using shukti after sthanika abhyanga & nadi sweda to urdhwa jatrugata pradesha followed by dhoomapana with haridra and sukhoshna saindhava jala) (1) Medicine Name: Prasarini Taila, Reference: Yoga Ratnakara, Route: Nasal, Dosage Form: Taila, Dose: 8(drops), Frequency: od, Duration: 7 Days |
|
|
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Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Subjects of either gender in between the age group of 18 to 70 years presenting with signs and symptoms of Cervical spondylosis and fit for Greeva Basti and Nasya karma will be selected. |
|
| ExclusionCriteria |
| Details |
Subjects presenting with history of major systemic disorder and history of traumatic infective and neoplastic conditions of spine. |
|
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Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Open Label |
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Primary Outcome
|
| Outcome |
TimePoints |
| There is statistically significant difference between the groups on pain stiffness radiation of pain paresthesia vertigo |
At baseline 7th day after treatment |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NA |
|
|
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 |
|
Date of First Enrollment (India)
|
26/03/2025 |
| 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="5" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
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Brief Summary
|
Cervical spondylosis can be considered as Vataja nanatmaja vyadhis occurring above clavicle and can be discussed under different headings Vishwachi, Greevahundana, Greevastambha, Manyastambha. etc. In order to counteract this condition, two distinct modalities of treatment are employed namely Nasya karma as Antah Parimarjana Chikithsa, Greeva Basti3,4 and Greeva Pichu as Bahi Parimarjana Chikithsa. The term Greeva Basti and Greeva Pichu are evolved from Shiro Basti5 and Shiro Pichu6 respectively. The taila used for these procedures does the Snehana and due to Agni samyoga it causes swedana effect too. Thus these can be considered under the category of Snigdha sweda. Though Greeva Basti evolved from the concept of Shiro Basti is widely practiced as a modality of Snigdha Swedana in the management of Cervical Spondylosis, it has its own limitations as far as covering minimal surface area usually the lower cervical spinal region and difficulty in maintaining the same posture without any neck movement throughout the entire course of treatment. Conventionally, Greeva Pichu which is evolved from the concept of Pichu and Shiro Pichu, can be considered as an alternative modality of Snigdha Swedana over Cervical region by considering its advantage in covering larger surface area as well as the flexibility in postural change during the treatment. And the same will be employed in the management of Cervical Spondylosis. In Charaka Samhita, Tila Taila is mentioned as “Vataghnesha uttamamâ€7 and in Sushrutha Samhita as “Sarve Anilanashanaâ€8. So Moorchita tila taila9 is employed for both Greeva Basti and Greeva Pichu. Nasya karma is considered as unique line of treatment in urdhwa jatrugata vikara10. While explaining Nasya Karma yogyas, Charaka mentions ‘Greeva skanda roga’11. Sushrutha mentions ‘Greevaskandorasaam cha balajananartham’12. Prasarini taila13is indicated in vatavyadhi and is described as useful in ‘sarva vatamaya’ and ‘vata jarjaritha nara’ and its utility in the form of Nasya Karma is described as ‘Prabhanjane shreshtam nasyakarmani shasyathe’. So, the same will be employed for Nasya Karma. Thus, by considering the above factors, a clinical study will be undertaken to evaluate the therapeutic efficacy of Greeva Basti and Nasya karma with Greeva Pichu and Nasya karma in Cervical Spondylosis. |