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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 
Public Title of Study   A Study on the effectiveness of selected panchkarma procedures in the management of facial nerve pain 
Scientific Title of Study   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 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
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  
 
Source of Monetary or Material Support  
National Institute of Ayurveda Jorawar Singh Gate, Amer road Jaipur, Rajasthan, India, PIN 302002 
 
Primary Sponsor  
Name  National Institute of Ayurveda 
Address  Jorawar Singh Gate, Amer road Jaipur, Rajasthan, India, PIN 302002 
Type of Sponsor  Government medical college 
 
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 
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 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, National Institute of Ayurveda  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:G09||Sequelae of inflammatory diseasesof central nervous system. Ayurveda Condition: ANANTAVATAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmProcedure-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
2Intervention ArmProcedure-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
3Intervention ArmProcedure-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
4Intervention ArmProcedure-lepa, लेप (Procedure Reference: shusruta sutra chapter 18, Procedure details: Bala Neelaotpala Durva Krishna Tila & Punarnava are rubbed with water & fine paste is made)
 
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
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Changes in Visual Analog Score.   Changes in Visual Analog Score.  
 
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
 
 
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 
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  

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.



  

 
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