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CTRI Number

CTRI/2025/03/082859 [Registered on: 19/03/2025] Trial Registered Prospectively

Last Modified On:

19/03/2025

Post Graduate Thesis

Yes

Type of Trial

Interventional

Type of Study

Drug
Ayurveda

Study Design

Randomized, Parallel Group Trial

Public Title of Study

To compare between the effect of shuddhabala taila nasya and karpasasthyadi taila nasya in the management of ardita

Scientific Title of Study

A randomized controled clinical study to evaluate the efficacy of shuddhabala taila nasya and karpasasthyadi taila nasya in the management of ardita

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 D Devi
Designation	PG Scholar
Affiliation	Shree Jagadguru Gavisiddheshwara Ayurvedic Medical College and Hospital
Address	Shree Jagadguru Gavisiddheshwara Ayurvedic Medical College and Hospital Department of Panchakarma koppal Koppal KARNATAKA 583231 India
Phone	7019716480
Fax
Email	7019716480d@gmail.com

Details of Contact Person
Scientific Query

Name	Dr Suresh N Hakkandi
Designation	Professor and HOD
Affiliation	Shree Jagadguru Gavisiddheshwara Ayurvedic Medical College and Hospital
Address	Shree Jagadguru Gavisiddheshwara Ayurvedic Medical College and Hospital Department of Panchakarma koppal Koppal KARNATAKA 583231 India
Phone	9448609362
Fax
Email	sureshhakkandi@gmail.com

Details of Contact Person
Public Query

Name	Dr Suresh N Hakkandi
Designation	Professor and HOD
Affiliation	Shree Jagadguru Gavisiddheshwara Ayurvedic Medical College and Hospital
Address	Shree Jagadguru Gavisiddheshwara Ayurvedic Medical College and Hospital Department of Panchakarma koppal Koppal KARNATAKA 583231 India
Phone	9448609362
Fax
Email	sureshhakkandi@gmail.com

Source of Monetary or Material Support

Shree jagadguru gavisiddeshwara ayurvedic medical college and Hospital koppal 583231

Primary Sponsor

Name	Dr D Devi
Address	Shree Jagadguru Gavisiddeshwara ayurvedic medical college and Hospital koppal 583231
Type of Sponsor	Other []

Details of Secondary Sponsor

Name	Address
NIL	NIL

Countries of Recruitment

India

Sites of Study

No of Sites = 1
Name of Principal Investigator	Name of Site	Site Address	Phone/Fax/Email
Dr D Devi	Shree Jagadguru Gavisiddheshwara Ayurvedic Medical College and Hospital koppal	Shree Jagadguru Gavisiddheshwara Ayurvedic Medical College and Hospital Department of Panchakarma Koppal Koppal KARNATAKA	7019716480 7019716480d@gmail.com

Details of Ethics Committee

No of Ethics Committees= 1
Name of Committee	Approval Status
Shree Jagadguru Gavisiddheshwara Ayurvedic medical college and Hospital koppal	Approved

Regulatory Clearance Status from DCGI

Status

Not Applicable

Health Condition / Problems Studied

Health Type	Condition
Patients	(1) ICD-10 Condition:G510\|\|Bells palsy. Ayurveda Condition: ARDITAH,

Intervention / Comparator Agent

sno	Intervention/Comparator	Type	Drug-Type	Procedure Name	Details
1	Intervention Arm	Procedure	-	nasyam/ nastam, नस्यम्/ नस्तम्	(Procedure Reference: Cha. Chi.28/96, Procedure details: Poorvakarma is Mukha Abhyanga with Tila Taila and Bhashpa Swedana, Pradhana karma Nasya karma with Shuddhabala Taila, Paschat karma Kawalagraha with Sukoshnajala and Dhumapana) (1) Medicine Name: Shuddhabala Taila, Reference: Sahasrayogam taila prakarana, Route: Nasal, Dosage Form: Taila, Dose: 4(ml), Frequency: od, Duration: 14 Days
2	Comparator Arm	Procedure	-	nasyam/ nastam, नस्यम्/ नस्तम्	(Procedure Reference: Cha. Chi.28/96, Procedure details: Poorvakarma is Mukha Abhyanga with Tila Taila and Bhashpa Swedana, Pradhana karma Nasya karma with Karpasasthyadi Taila, Paschat karma Kawalagraha with Sukoshnajala and Dhumapana) (1) Medicine Name: Karpasasthyadi Taila, Reference: Sahasrayogam Taila prakarana, Route: Nasal, Dosage Form: Taila, Dose: 4(ml), Frequency: od, Duration: 14 Days

Inclusion Criteria

Age From	14.00 Year(s)
Age To	60.00 Year(s)
Gender	Both
Details	Patient presenting with classical signs and symptoms of Ardita Patients from either sex were selected in the age group of 14-60 years. Patients fit for Nasya Karma

ExclusionCriteria

Details

More than 3 years of history.
Ardita associated with Pakshagata, Bilateral facial nerve paralysis, intracranial hemorrhage,
neoplasm, Multiple sclerosis.
Patient with other systemic disorders which interfere with course of treatment, and auto
immune disorders.
Un-controlled diabetic mellitus.
Pregnant women.

Method of Generating Random Sequence

Computer generated randomization

Method of Concealment

On-site computer system

Blinding/Masking

Open Label

Primary Outcome

Outcome	TimePoints
To evaluate the efficacy of Shuddhabala taila nasya in the management of ardita	6 months

Secondary Outcome

Outcome	TimePoints
To compare the efficacy of karpasasthyadi taila nasya & shuddhabala taila nasya in the management of ardita	6 months

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 3

Date of First Enrollment (India)

30/03/2025

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="0"
Months="6"
Days="0"

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

Brief Summary

6.1 NEED FOR THE STUDY:

Ardita is considered as one among the 80 Vataja nanatmaja vyadhi in Ayurvedic classics.¹The word ardita means partially deviated. ’Ardyitva anile vaktramardita Janayatyataa.²As per Ayurveda excessively aggravated Vayu causes the Mukha vakratvam, Lalaata vali naasham, Akshi nimesha asamarthya, Vaksanga, Greeva chibuka dantha vedana etc.

Ardita can be correlated in contemporary medicine with Facial paralysis, which means a loss of facial movements due to facial nerve damage. It can come on suddenly or happen gradually over a period of months, depending on the cause. Bell’s palsy is an idiopathic Facial paralysis, which has an acute-onset/develops suddenly, unilateral, lower motor neuron facial weakness, symptoms may include muscle weakness, drooping of the eyelid, drooping mouth, slurred speech, and inability to hold water in mouth.³ It occurs widely all over the world, management is somewhat difficult, sometimes living Synkinesis. Face major tool of communication for human interaction is badly affected with this, also chance of recurrence is greater, annual incidence varies in different parts of the world, with estimates varying between 10 to 40 per 1 Lakh people per year.⁴ It is more common in young adults, diabetic patients and women are more prone to this disorder.

Modern treatment for Bell’s Palsy will be steroids, Analgesics, surgical management, which causes severe side effects on body. In ayurveda treatment described for Ardita is safe and effective. The treatment provides strengthens to facial muscles and nerves. Acharya’s have highlighted in the context of Nasya as one among the important procedure of Panchakarma which is indicated in Ardita, and especially Navana Nasya⁵. Ardita is one among the Urdhawajatrugata Vikara, in which Nasya Karma is considered as Sarva Shresta. The drug administered through nose its reaches to Shringataka Marma from where it spreads into various Strotas (vessesls and nerves) and alleviates the vitiated Dosha.

Karpasasthydi Taila⁶is mainly indicated in Ardita. Shuddhabala Taila⁷is effective Taila for management of Vatavyadhi and it has properties of Vatahara, Balya. Hence present study is undertaken as a Randomized controlled clinical study to evaluate the efficacy of Karpasasthyadi Taila Nasya and Shuddhabala Taila Nasya.

6.2 REVIEW OF LITERATURE:

1. The wide descriptions about Ardita, Nasya Karma will be reviewed from Bruhatrayaees^8,9,10& other classical texts¹¹.

2. About Facial paralysis will be reviewed from contemporary medical science texts, recent articles, internet.

3. Descriptions about Shuddhabala Taila and Karpasasthyadi Taila will be reviewed from Sahasra yoga.

6.3 PREVIOUS WORK DONE:

1. Dr.L.Pavithra saran- “To evaluate the efficacy of Vishnutaila Nasya in the management of Ardita w.s.r to Bell’s Palsy”. SJGAMC post graduate studies & research center, koppal.2014.

2. Dr.Venkata ravi Krishna- effect of Mashabaladi Nasya and BalaksheeraDhooma in Ardita.N.K.Jabshetty ayurvedic medical college, bidar, 2005.

3. Dr.Tatpiyenitin AV- a clinical study on Arditaroga w.s.r to Navananasya and Shiropichu,Samiti’s ayurved Mahavidyalaya ,bijapur,2001.

4. Dr. Mallaran D- therapeutic effect of Kokkutanda Nimbarka Swedam on Arditavata Kottakkal Ayurveda college, 1990.

5. Dr. Panakala Rao K- effect of Nirgundi Taila nasya on Ardita Vata, Kottakkal Ayurveda college,1985.

6.4 OBJECTIVES OF THE STUDY:

· To evaluate the efficacy of Shuddhabala Taila Nasya in the management of Ardita.

· To evaluate the efficacy of Karpasasthyadi Taila Nasya in the management of Ardita

· To compare the efficacy of Karpasasthyadi Taila Nasya and Shuddhabala Taila Nasya in the management of Ardita.

6.5 HYPOTHESIS

· H_o-There is a no significant difference in the effect of Shuddhabala Taila Nasya and Karpasasthyadi Taila Nasya in the management of Ardita.

· H₁-There is a significant effect of Shuddhabala Taila Nasya over Karpasasthyadi Taila Nasya in management of Ardita.

· H₂- There is a significant effect of Karpasasthyadi Taila Nasya over Shuddhabala Taila Nasya in management of Ardita.

7. MATERIALS AND METHODS:

7.1 SOURCE OF DATA:

A) Literary source:

It will be reviewed from Bruhatrayaees and other classical texts, contemporary texts and authenticated journals.

B) Sample source:

Patients suffering from the Ardita will be selected randomly from the OPD of SJGAMC Hospital, Koppal.

C) DRUG SOURCE:

All ingredients of Shuddhabala Taila and Karpasasthyadi Taila drugs will be collected and identified by Dravyaguna Department and prepared in the Rasashastra and Bhaisajya Kalpana department of SJG Ayurvedic medical college and hospital PG studies, Koppal according to standard procedure mentioned in classics.

TABLE NO:01 SHUDDHA BALA TAILA

S.N	DRUGS	BOTANICAL NAME	PART USE	MATRA
01	Bala moola kalka	Sida cardifolia	Moola	10 Pala
02	Tila taila	Sesame indicum	Phala,Taila	4 Prastha
03	Balamoola Kashaya	Sida cardifolia	Moola	100 Pala
04	Goksheera	Cow milk	Ksheer	8 Prastha

S.N	DRUGS	BOTANICAL NAME	PART USE	MATRA
1	Devadaru	Cedrus deodara	heartwood	1/11 part
2	Bala	Sida cardifolia	Moola	1/11 part
3	Rasna	Pluchea lanceolata	Moola	1/11 part
4	Kushta	Saussurea lappa	Twak	1/11 part
5	Sarshapa	Brassica juncea	Beeja	1/11 part
6	Nagara(sunti)	Zingiber officinais	Moola	1/11 part
7	Satahwa	Anethum sowa	panchanga	1/11 part
8	Pippalimoola	Piper longum	Moola	1/11 part
9	Chavya	Piper retrofractum	Fruit	1/11 part
10	Shigru	Moringa oleifera	Patra	1/11 part
11	Punarnava	Boerlaavia diffusa	Panchanga	1/11 part
12	Tilataila	Sesamum indicum	Phala,taila	4 parts
13	Ajaksheera	Goat’s milk	Ksheera	4 parts
14	Karpasasthi	Gossypiumherbaceu	Beeja	¼ part
15	Balamoola	Sida cardifolia	Moola	¼ part
16	Masha	Phaseolusradiatus	Beeja	¼ part
17	Kulattha	Dolichosbiflorus	Beeja	¼ part

TABLE NO: 02 KARPASASTHYADI TAILA.

7.2 METHOD OF DATA COLLECTION:

I) STUDY DESIGN:

An open label randomized controlled clinical study.

II) SAMPLE SIZE AND GROUPING:

A minimum of 40 subjects will be selected for the study and they will be randomly allocated in 2 groups.

Group A: 20 subjects will receive: Shuddhabala Taila

Group B: 20 subjects will receive: Karpasasthyadi Taila.

III) SELECTION CRITERIA:

A) DIAGNOSTIC CREITERIA:

The diagnosis of the disease is mainly based on the classical signs and symptoms of Ardita mentioned in texts. Mukha Vakratvam, Stabdha Netra, Vaak Sanga, Lalaata Vali Nasha, Akshi Nimesha Asamarthya, Greeva Chibuka Dantha Vedana.

B) INCLUSION CRITERIA

1. Patient presenting with classical signs and symptoms of Ardita.

2. Patients from either sex were selected in the age group of 14-60 years.

3. Patients fit for Nasya Karma.

C) EXCLUSION CRITERIA

1. More than 3 years of history.

2. Ardita associated with Pakshagata, Bilateral facial nerve paralysis, intracranial hemorrhage, neoplasm, Multiple sclerosis.

3. Patient with other systemic disorders which interfere with course of treatment, and auto immune disorders.

4. Un controlled diabetic mellitus.

5. Pregnant women.

D) STUDY GROUPS: -

GROUP A

GROUP B

POORVAKARMA

Mukha abhyanga with Tila Taila & Bhashpa Swedana.

PRADHANAKARMA

Nasya Karma with ShuddhabalaTaila

Dose-8Bindu (4ml)¹²for 14 days.

Nasya Karma with Karpasasthyadi Taila

Dose-8Bindu (4ml)for 14days.

PASCHAT KARMA

Kavalagraaha with Sukoshnajala and

Dhumapana.

E) STUDY DURATION:

For both groups:

Treatment duration - 14days.

Parihara kaala - 28 days.

Total study duration - 42days.

F) ASSESMENT CRITERIA:

On the basis of scoring of subjective parameters, the samples will be assessed.

i. SUBJECTIVE PARAMETERS-

1.Greeva Chibuka Dantha Vedana.

0	Normal.
1	Vedana limited to only one site/ only at night/ morning.
2	Vedana on half of the affected side (intermittent).
3	Vedana all over the affected side (constant).

2.House-Brackmann facial nerve grading scale.¹³

GRADE	FUNCTION
1	Normal
2	Normal at rest, slight weakness on close inspection, complete eye closure with minimal effort, slight asymmetry of mouth with movement, good to moderate forehead movement.
3	Normal at rest, Obvious Asymmetry on movements, synkinesis hemifacial spasm, complete eye closure with effort, slight to moderate forehead movements, slight weakness of mouth with maximal effort.
4	Normal at rest, Asymmetry on movement is disfiguring, incomplete eye closure, no perceptible forehead movement, Asymmetrical mouth motion with maximal effort.
5	Asymmetric at rest, barely noticeable movement, no forehead movement, incomplete eye closure, slight mouth movement with effort.
6	No facial function perceptible.

3.Vaksanga

0	Normal Speech/ pronunciation.
1	Inadequate clarity of speech/ unable to pronounce the vowels.
2	Poor clarity of speech/ simple word cannot be pronounced.
3	No speech/complete absence of pronunciation.

Based on the clarity and pronunciation.

0	Normal.
1	Inflates, but air escapes slowly (on gentle taping).
2	Inflates with difficulty, but air escapes slowly.
3	Unable to inflate.

4. Mouth Inflation test (Based on the strength and withholding capacity of the Facial muscles)

7.3) STATISTICAL TEST-

· Subjective parameter parameter of base line data before, after treatment and follow up will be compared to assess the result using Wilcoxon Signed Rank, Mann Whiteney U test will be carried out.

7.4) Does the study require any Investigation or intervention to be conducted on patients?

Yes.

INVESTIGATION (will be carried out for diagnostic and exclusion purpose if necessary)

RBS, ESR, CT brain.

7.5) Has Ethical Clearance been obtained from your institution?

Yes, Obtained and enclosed.

08. LIST OF REFERENCES

1.R.K. Sharma, Bhagwan Das; Charaka Samhita, SutraSthana, chapter 20, sloka no 11; Varanasi Chowkhamba Sanskrit series office, edition: reprint:2017, pg no 363.

2. Kaviraj Ambikadutta Shastri, Susruta Samhita, Nidana Sthana, chapter 01 sloka no 68-73; Varanasi

Chaukhamba Sanskrit Sansthan, edition: reprint:2021, pg no 303.

3. DOI: 10.21760/jaims. v1i1.3643, Ayurvedic management of Ardita – A case report, may-June 2016.

4. DOI: 10.4103/JISM_80_20. Management of Ardita through Ayurveda: A case series, Feb 11,2021.

5. R.K.Sharma Bhagwan Das; Charaka Samhita, Chikista Sthana, chapter28, sloka no 99; Varanasi, Choukamba Sanskrit series, edition: reprint: 2018, pg.no 31-32.

6. Shri P R Krishnakumarji, Sahasra yoga, Taila Prakarana, Varanasi, Chowkhamba Sanskrit series office, edition first 2006, edition second 2008, pg .no 118.

7. Shri P R Krishnakumarji, Sahasra yoga, Taila Prakarana, Varanasi, Chowkhamba Sanskrit series office, edition first 2006, edition second 2008, pg .no 110.

8. R.K. Sharma Bhagwan das; Charaka Samhita, Chikista Sthana, chapter28, sloka no 99; Varanasi, Choukamba Sanskrit series, edition: reprint: 2018; pg.no 31-32.

9. Kaviraj Ambikadutta Shastri, Susruta Samhita, Chikista Sthana, chapter 5, sloka no 22, Varanasi, Chaukhamba Sanskrit Sansthan, edition: reprint:2021, pg no 43.

10. Prof K.R.Srikanthamurthy; Astanga hrdayam; Nidana Sthanam, chapter 15, sloka no 32-37; Varanasi, Chaukambha Krishnadas Academy, 5^th edition 2003, pg.no 154-155.

11.Dr. Indrabevva Tripathi, Cakradatta Chikitsa Chapter 22 sloka 17-18, Varanasi, Chaukhamba Sanskria Samsthan, edition 1997.

12.Yogeshwar R Chippa, Sachin S Chandaliya, Varsha N Sane, Pournima Daware Mayura Jadhab, Standardization Of Bindu For Nasya, IJAR 2016; Volume 4, pg no-895-901(DOI: 10.21474/IJAR01).

13.Michael Glynn, William m darke, Hutchiso’s clinical methods,24^thedition 2018, pg no 446.