| CTRI Number |
CTRI/2025/04/085780 [Registered on: 28/04/2025] Trial Registered Prospectively |
| Last Modified On: |
25/04/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A study to compare the effect of Nasya with Nasapana using Dashamooladi kashaya in the treatment of Vishwachi |
|
Scientific Title of Study
|
A RANDOMIZED CONTROLLED CLINICAL STUDY ON THE EFFECT OF NASYA AND NASAPANA WITH DASHAMOOLADI KASHAYA IN THE TREATMENT OF VISHWACHI (CERVICAL RADICULOPATHY) |
| 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 Shruti Kundaragi |
| Designation |
Post graduate scholar |
| Affiliation |
Shri Jagadguru Gavisidheshwar Ayurvedic Medical College Koppal |
| Address |
Shree Jagadguru Gavisiddheshwara Ayurvedic Medical College Gavimath Campus Koppal
Koppal KARNATAKA 583231 India |
| Phone |
8105378027 |
| Fax |
|
| Email |
shruthikundaragi@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Latha L U |
| Designation |
Associate Professor |
| Affiliation |
Shri Jagadguru Gavisidheshwar Ayurvedic Medical College Koppal |
| Address |
Shree Jagadguru Gavisiddheshwara Ayurvedic Medical College Gavimath Campus Koppal
Koppal KARNATAKA 583231 India |
| Phone |
9980879649 |
| Fax |
|
| Email |
dr.lathalu7@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Latha L U |
| Designation |
Associate Professor |
| Affiliation |
Shri Jagadguru Gavisidheshwar Ayurvedic Medical College Koppal |
| Address |
Shree Jagadguru Gavisiddheshwara Ayurvedic Medical College Gavimath Campus Koppal
Koppal KARNATAKA 583231 India |
| Phone |
9980879649 |
| Fax |
|
| Email |
dr.lathalu7@gmail.com |
|
|
Source of Monetary or Material Support
|
| Shree Jagadguru Gavisiddheshwara Ayurvedic Medical College and Hospital, Koppal, Karnataka, India - 583231 |
|
|
Primary Sponsor
|
| Name |
Dr Shruti Kundaragi |
| Address |
Department of Panchakarma , Shree Jagadguru Gavisiddheshwara Ayurvedic Medical College and Hospital Gavimath Campus, Koppal, Karnataka, India - 583231 |
| Type of Sponsor |
Other [Self] |
|
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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 Shruti Kundaragi |
Shree Jagadguru Gavisiddheshwara Ayurvedic Medical College, Koppal |
Panchakarma Unit, Department of Panchakarma, Shree Jagadguru Gavisiddheshwara Ayurvedic Medical College Gavimath Campus , Koppal, Karnataka, India - 583231 Koppal KARNATAKA |
8105378027
shruthikundaragi@gmail.com |
|
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Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Shree Jagadguru Gavisiddeshwara Ayurvedic Medical College and Hospital, Koppal |
Approved |
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Regulatory Clearance Status from DCGI
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:G563||Lesion of radial nerve. Ayurveda Condition: VISVACI, |
|
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Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | nasyam/ nastam, नस्यम्/ नस्तम् | (Procedure Reference: R H Singh, foreword by Prof P V Sharma; Panchakarma therapy, chowkhamba publication Varanasi, Reprint on 2014, page no 139, Procedure details: I. NASYA
Materials required – Gokarnika, Murchita Tila Taila, Dashamooladi Kashaya.
Purva Karma:
• Subjects advised to have light food at the evening time (6pm).
• Subjects will be advised to remain relaxed, Sthanika Abhyanga to face and affected part will be done with murchita Tila Taila followed by Sthanika Bhashpa sweda, till the appearance of Samyak swinna lakshanas.
• Care of the eyes should be taken by covering the eyes with a band of wet cloth.
Pradhana Karma:
• Subject will made lie comfortably in supine position by tilting his head little lowered by keeping the pillow below the neck.
• Then the 8 Bindu of freshly prepared luke warm Dashamooladi Kashaya will be instill into each nostril by keeping the other nostril closed, Nasal secretions were advised to be spitted out.
Paschat Karma:
• Kavala with Sukhoshna Saindhava Jala.
• Special advice will be given to Subjects to avoid exposure to wind, dust, smoke and direct sunlight and to use warm water for drinking or bathing and light food to have.) (1) Medicine Name: Dashamooladi Kashaya, Reference: 13. Priyavrata sharma, chakradatta, Sanskrit text with English translation,12/24, Varanasi, chaukambha publications, edition 2007,186, Route: Nasal, Dosage Form: Kwatha/Kashaya, Dose: 12(ml), Frequency: od, Duration: 7 Days | | 2 | Comparator Arm | Procedure | - | nAvanam, नावनम् | (Procedure Reference: 15. Naik, shruti &patil, vaidya vasanth. (2022) STANDARDIZATION OF NASAPANA PROCEDURE USING SYRINGE AND NETI POT METHOD IN PATIENTS OF AVABAHUKA, Procedure details: II. NASAPANA
Materials required – Jala Neti, Murchita Tila Taila, Dashamooladi Kashaya.
Purva Karma:
• Patient will be advised to have light food at the evening time (6PM)
• Vitals will be monitored.
• Sthanika Abhyanga to face and affected part will be done with luke warm Murchita Tila Taila followed by Sthanika Bhashpa sweda till the appearance of Samyak Swinna Lakshanas. Care of the eyes should be taken by closing with a band of wet cloth.
Pradhana Karma :
• Subject will be asked to stand Comfortably, leaning forward tilting the head to one side.
• Subject will be asked to breathe out forcefully in order to sniff the foreign bodies, to avoid nasal obstruction and ease the procedure.
• The luke warm freshly prepared Dashamooladi Kashaya will be taken in the Neti Pot. The Pot’s spout will be inserted gently in one nostril of subject.
• Subject will be asked to sit on the chair comfortably and Breathe through mouth keeping it open. The freshly prepared Dashamooladi Kashaya will be slowly poured into nostril by tilting the head little lowered and it will be allowed to drink by closing the other nostril.
• For this group of patients – Increasing dose i.e Starting from 12ml and increasing 2ml daily till 7th day (24ml dose) for each nostril.
• The nose will be dried by bending forward and Kapalabhati.
Paschat Karma:
• After the procedure , Subjects will be asked to lie supine position for couple of minutes.
• Subject will be advised for Kavala with Sukhoshna saindhava jala.
• Diet and regimen will be prescribed subsequently.
) (1) Medicine Name: Dashamooladi Kashayam, Reference: 14. Priyavrata sharma, chakradatta, Sanskrit text with English translation, 12/26, Varanasi, chaukambha publications, edition 2007, 186, Route: Nasal, Dosage Form: Kwatha/Kashaya, Dose: 12(ml), Frequency: od, Duration: 7 Days |
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|
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Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Subjects fit for Nasya and Nasapana procedure.
Subjects presenting with Pratyatma lakshana of vishwachi.
Subjects presenting with complaints of Cervical Radiculopathy.
Subjects of either gender aged between 18 to 60 years will be selected.
|
|
| ExclusionCriteria |
| Details |
Subjects unfit for Nasya and Nasapana except Bhuktabhakta.
Subjects having grade 3 adenoids , Grade 3 Deviated nasal septum, Grade 3 turbinate hypertrophy, grade 3 nasal polyp, Acute rhinitis,, concha bullosa etc. which hinders in smooth performance of Nasya and Nasapana.
Subjects having non communicable diseases (NCD) such as uncontrolled diabetes and Hypertension.
Subjects with Fracture of Cervical spine.
Pregnant and lactating women.
Post operated case of Cervical Radiculopathy. |
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Method of Generating Random Sequence
|
Computer generated randomization |
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Method of Concealment
|
An Open list of random numbers |
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Blinding/Masking
|
Open Label |
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Primary Outcome
|
| Outcome |
TimePoints |
| Reduce Pain and Increase range of movement in Cervical Radiculopathy |
Total treatment Duration - 7 Days for both the groups.
Follow-up Duration - 14 days for both the groups.
Total Study Duration - 21 days for both the groups.
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| nil |
nil |
|
|
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 4 |
|
Date of First Enrollment (India)
|
07/05/2025 |
| 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="0" Months="10" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
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Publication Details
|
N/A |
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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
|
We are living in a world of bullet trains, AI (Artificial intelligence),
and automation, where everything around is moving fast. Today’s lifestyle has
led to various disease conditions that don’t necessarily cause death, but can
significantly disrupt day to day life. One
such condition is Vishwachi,
affecting upper limbs. It
is one of the most common type of Vata
vyadhi found in clinical practice, in which the Prakupita vata affects the Kandara
of Bahu, it is a disorder
typically occurs during the most active years of life, characterized by Teevra ruja, Ruk, Stamba, Toda,
Karmakshaya, Bahu cheshtapaharana. Pratyatma lakshana of Vishwachi is radiating pain from the Bahu Prishta to the Hastathalam and Pratyanguli, Acharya
Dalhana opines that this condition is similar to Gridhrasi and has two types – Vataja
and Vatakaphaja. Being a Shoola pradhana vataja nanatmaja
vyadhi, it deprives the patient’s ability to perform movements
of upper limb which in turn makes them unable to carry their routine work. In Allopathy medicine, this condition
can be correlated to Cervical Radiculopathy, Cervical radiculopathy is a
neurologic condition characterized by dysfunction of a cervical spinal nerve,
the roots of the
nerve, or both.
It usually presents with pain in
the neck and one arm, with a combination of sensory loss, loss of motor function,
or reflex changes in the
affected nerve-root distribution. It is associated
with movement impairment of the upper limbs in 68% of the cases, scapular pain
in 52.5% of cases, paraesthesia in 45.5% of the cases, among others. It’s also
associated with diminish Musculoskeletal reflexes. The most common cause of
Cervical Radiculopathy is the result of degenerative changes that affect the
anatomy of the cervical spine including the vertebral bodies, the intra
vertebral discs, the facet joints and the ligament component of cervical spine. Cervical radiculopathies occur at an incidence rate of approximately 85 persons
per 100,000. The C7 nerve root is most frequently impacted, with more than half
of all cases affecting this level. Roughly a quarter of cases involve the C6
nerve root. Nerve roots C1 to C5 and C8 are less impacted. Risk factors for
developing radicular disease include manual labour with heavy lifting, driving,
or operating vibrating equipment. Chronic smoking history can increase the risk
of radiculopathies. The main goal of treatment in this illness is
to alleviate pain , hence analgesics, muscle relaxants, and physiotherapy are
all administered. People are turning to Ayurveda to discover a better solution
for this ailment due to the negative side effects of pain relievers and
surgery. Nasya, an essential part of Panchakarma, has its mesmerizing effect
on almost all Urdhwajatrugata vata vyadhis which is already proven by several researches. The hidden element in Nasya, an inevitable therapy leading to
another important procedure called Nasapana,
an unique contribution given by Acharya
chakradatta and has also mentioned in several context by different acharyas. The words "nasyanipeeto", "pibennasyam" are used
in the contexts of Nasapana. The lack
of extensive literature, standard guidelines on this procedure and dosage of Nasapana has led to its limited
practice. however, on the basis of some recent SOP (standard
operating procedure) this procedure will be carried out. when Nasya karma is
compared with Nasapana, basic difference
is seen with dosage. All preparations are in Kashaya form for Nasapana
with large doses compared to Nasya
dosage. Hence
when large dose in Kashaya is given,
definitely has more residence time for Aushadha
dravya and thus there is better nasal drug absorption. Some researches
proved that, A slight modification in internal usage in the form of Nasapana can give combined effect of Nasya as well as Pana and may be more beneficial by cut shorting the time and
frequency of multiple medicament administration i.e Nasya along with conservative medicine usage. This single procedure
can save the time as well as it may gives more benefits than Nasya or Pana. Hence an attempt is made to compare the effect
of Nasya and Nasapana using Dashamoolaadi
kashaya. Most of the dravyas in
Dashamooladi Kashaya has Vatahara and
Brihmana Property which can mitigate
the shoola pradhana vataja nanatmaja vyadhi
called Vishwachi.
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