| CTRI Number |
CTRI/2026/01/102208 [Registered on: 27/01/2026] Trial Registered Prospectively |
| Last Modified On: |
24/01/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug Ayurveda |
| Study Design |
Single Arm Study |
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Public Title of Study
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A Study on the effectiveness of selected panchkarma procedures in the management of facial nerve pain |
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Scientific Title of Study
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An Open Label clinical trial to evaluate the efficacy of selected Panchkarma Procedures in the management of Anantvata with special reference to Trigeminal Neuralgia |
| Trial Acronym |
NIL |
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Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
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Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Priya Sharma |
| Designation |
MD Scholar |
| Affiliation |
National Institute of Ayurveda |
| Address |
Panchkarma Department,National Institute of Ayurveda, Jorawar Singh Gate, Amer Road, Jaipur
Jaipur RAJASTHAN 302002 India |
| Phone |
07889623737 |
| Fax |
|
| Email |
priyajkb@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Professor Dr Gopesh Mangal |
| Designation |
Professor and head of Department of Panchkarma |
| Affiliation |
National Institute of Ayurveda |
| Address |
Room No. 114, Panchkarma Department, National Instituite of Ayurveda, Jaipur
Jaipur RAJASTHAN 302002 India |
| Phone |
8619849011 |
| Fax |
|
| Email |
gmangal108@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Professor Dr Gopesh Mangal |
| Designation |
Professor and head of Department of Panchkarma |
| Affiliation |
National Institute of Ayurveda |
| Address |
Room No. 114, Panchkarma Department, National Instituite of Ayurveda, Jaipur
Jaipur RAJASTHAN 302002 India |
| Phone |
8619849011 |
| Fax |
|
| Email |
gmangal108@gmail.com |
|
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Source of Monetary or Material Support
|
| National Institute of Ayurveda Jorawar Singh Gate, Amer road Jaipur, Rajasthan, India, PIN 302002 |
|
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Primary Sponsor
|
| Name |
National Institute of Ayurveda |
| Address |
Jorawar Singh Gate, Amer road Jaipur, Rajasthan, India, PIN 302002 |
| Type of Sponsor |
Government medical college |
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Details of Secondary Sponsor
|
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Countries of Recruitment
|
India |
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Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Professor Dr Gopesh Mangal |
National Institute of Ayurveda |
Panchkarma Department, OPD number 2,Main Hospital Building,Jorawar Singh Gate, Amer Road , Jaipur, RAJASTHAN Jaipur RAJASTHAN |
8619849011
gmangal108@gmail.com |
|
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Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, National Institute of Ayurveda |
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:G09||Sequelae of inflammatory diseasesof central nervous system. Ayurveda Condition: ANANTAVATAH, |
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Intervention / Comparator Agent
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| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | nasyam/ nastam, नस्यम्/ नस्तम् | (Procedure Reference: , charak sidhi 9/88, Procedure details:
Mridu abhyanga and swedana on forehead, face and neck Pateints lie down on Nasya table in a supine position with an extended neck. Lukewarm with karpasasthyadhi taila will be instilled into one nostril while another nostril kept close. The same process will be performed for another nostril followed by dhoompana. the duration of trial is 15 days) (1) Medicine Name: Karpasasthyadhi taila, Reference: Sahasrayogam, Route: Nasal, Dosage Form: Taila, Dose: 8(drops), Frequency: od, Duration: 15 Days | | 2 | Intervention Arm | Procedure | - | Kukkutanda Sweda | (Procedure Reference: shree brhma shankar Mishra Bhavprakash madhyam khand , vata vayadhi 24/77, Procedure details: The oil is taken in a vessel and heated and sliced lemon, ajwain, methi, lashun, haridra and kolakuthadhi churna are added to it. Once the ingredient are fried, add 4-5 eggs without shell and stirred well till it attained semisolid consistency and were cooked properly.The soft lumps were then placed over cotton cloth and tried into pottali.) (1) Medicine Name: Kukkutanda Sweda, Reference: shree brhma shankar Mishra Bhavprakash madhyam khand , vata vayadhi 24/77, Route: Topical, Dosage Form: Not Applicable, Dose: 2(NA), Frequency: od, Duration: 15 Days | | 3 | Intervention Arm | Procedure | - | gaNDUShaH, गण्डूषः | (Procedure Reference: Sharangdhar U.K.10, Procedure details: dose of taila is 50 ml and it should be taken empty stomach through oral route. it should be retained until kanthasrava and akshisrava) (1) Medicine Name: Karpasasthyadhi Tailam, Reference: Sahasrayogam, Route: Oral, Dosage Form: Taila, Dose: 50(ml), Frequency: od, Duration: 15 Days | | 4 | Intervention Arm | Procedure | - | lepa, लेप | (Procedure Reference: shusruta sutra chapter 18, Procedure details: Bala Neelaotpala Durva Krishna Tila & Punarnava are rubbed with water & fine paste is made)
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Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Age group between 40-60yrs
Paroxysmal attacks of pain lasting from a fraction of a second to 2 min affecting one or more divisions of the trigeminal nerve.
Pain has at least one of the following characteristics
Intense, sharp, superficial or stabbing
Precipitated from trigger areas or by trigger factors.
Attacks are stereotyped in the individual patient.
Patients having clinical signs and symptoms of Anantvata like Manyapaschad ghatasu vednam (pain in sternomastoid region and at the back of neck) Spandnam gandasyaparshwa(throbbing pain in sides of cheeks) Netraroga(eye diseases) Hanugreham (lock jaw) Tivra kurvati akshibrhushankhevavtishthe (Pain in eyes and along the eyebrows)
|
|
| ExclusionCriteria |
| Details |
Having undergone Trigeminal Neuralgia-related surgical treatment.
Having a clear history of neurological diseases such as brain trauma, Cerebral Hemorrhage, or Brain Tumors.
Patients with a history or risk of seizures or a history of Epilepsy, Head injury or related Neurological disorders.
Patients with a history of poorly controlled and uncontrolled Hypertension (above150/100 mm of Hg)
Pregnant and Lactating women
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Method of Generating Random Sequence
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Computer generated randomization |
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Method of Concealment
|
Not Applicable |
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Blinding/Masking
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Open Label |
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Primary Outcome
|
| Outcome |
TimePoints |
| Changes in Visual Analog Score. |
Changes in Visual Analog Score. |
|
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Secondary Outcome
|
| Outcome |
TimePoints |
Changes in sign and symptoms of Anantvata.
Changes in HADS Scale.
|
- Continuous monitoring throughout the study
Specific assessments on Day 0, Day 15, Day 30
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Target Sample Size
|
Total Sample Size="30" Sample Size from India="30"
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)
|
01/07/2026 |
| 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="6" Days="28" |
|
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
|
Trigeminal Neuralgia is the most debilitating form of neuralgia affecting the sensory branches of 5th cranial nerve (Trigeminal nerve). Trigeminal Neuralgia (TN) is a unilateral disorder characterized by excruciating paroxysmal severe, brief, stabbing, lancinating, recurring pain in the distribution of one or more branches of Trigeminal nerve affecting ear, lips, gums, cheek, or chin and very rarely in the distribution of the ophthalmic division of the trigeminal nerve. The ‘typical’ or ‘classic’ form of the disorder (Type 1 or TN 1) causes extreme sporadic sudden burning or shock like facial pain that lasts anywhere from a few seconds to as long as 2 minutes per episode. The ‘atypical’ form of the disorder (Type 2 or TN 2) is characterized by constant aching, burning, stabbing pain of somewhat lower intensity than type 1. Chewing, speaking, washing the face, tooth brushing, cold winds or touching a specific ‘trigger spot’ e.g. upper lip or gum may all precipitate an attack of pain. TN more commonly affects females and patients over 50yrs of age. The Pain rarely occurs bilaterally and never simultaneously on each side; occasionally more than one division is involved. In Ayurveda Acharya Sushruta has described disease named Anantvata under 11 Shirorogas. In this disease all the three Doshas are vitiated. Hence the disease is said to be Tridoshaj Vyadhi. While explaining the symptoms of the disease Acharya has said that the Doshas affect the Manya which is Siramarma and causes severe pain in the Ghata that is the Prushtha Bhaga of the Griva (back side of the neck), Akshi (eyes), Bhru (eyebrows), Shankha Pradesha (temples). There is also Spandan in the Ganda Parshva Pradesha (spasm in the cheek), Netrarogam (eye diseases) and Hanugraham (spasm of temporomandibular joint). According to signs and symptoms, Anantavata can nearly correlate with Trigeminal Neuralgia. Trigeminal neuralgia affects 4 to 13 out of every 100,000 people per year. It is more common in women than in men, with a female-to-male prevalence ratio ranging from 1.5 to 1.7 to 1. Most cases occur after the age of 50, but the condition can also appear in people in their 20s and 30s, though it is rarely diagnosed in childhood. Research on Trigeminal Neuralgia is important because it is a severely disabling pain condition that greatly affects quality of life. Currently, there is no definitive cure, making it necessary to further investigate its underlying mechanisms in order to develop more effective and targeted treatment options. Carbamazepine is the first-line treatment for trigeminal neuralgia. However, in this case, despite taking these medications for a long time, the patient did not experience significant improvement. Modern science is pharmacological and surgical but not effective as recurrence is very common. In ayurveda anantvata is managed according to dosha and their adhisthana. Anantavata is urdwajatrugata vikara for which nasya is considered best modality. Shaman chikitsa after Shodhan is required for better outcomes. |