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CTRI Number  CTRI/2024/04/066123 [Registered on: 23/04/2024] Trial Registered Prospectively
Last Modified On: 22/04/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Single Arm Study 
Public Title of Study   Effect of Indravaruni oil in the management of tremors 
Scientific Title of Study   Effect of Indravaruni (Colocynth Citrullus schrad.) in the management of Kampa w.r.t tremors- an open-labelled clinical trial. 
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 Meghana Ghanti 
Designation  PG scholar Dravyaguna department 
Affiliation  KLE shri BMK ayurveda mahavidyalaya 
Address  KLE BMK Ayurveda Mahavidyalaya Shahpur near nathpai circle Belagavi

Belgaum
KARNATAKA
590003
India 
Phone  9108703306  
Fax    
Email  meghanaghanti15@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Arun Chougale 
Designation  MD Ayu professor and HOD Dravyaguna Department 
Affiliation  Kaher shri BM Kankanwadi Ayurveda Mahavidyalaya 
Address  Kaher shri BM Kankanwadi Ayurveda Mahavidyalaya shahpur Belagavi

Belgaum
KARNATAKA
590003
India 
Phone  9964749993  
Fax    
Email  punarjeevam@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Arun Chougale 
Designation  MD Ayu professor and HOD Dravyaguna department 
Affiliation  Kaher shri BM Kankanwadi Ayurveda Mahavidyalaya 
Address  Kaher shri BM Kankanwadi Ayurveda Mahavidyalaya shahpur Belagavi Dravyaguna department

Belgaum
KARNATAKA
590003
India 
Phone  9964749993  
Fax    
Email  punarjeevam@gmail.com  
 
Source of Monetary or Material Support  
KAHERS Shri BMK Ayurveda Mahavidyalaya shahpur Belagavi Karnataka India 590003 
 
Primary Sponsor  
Name  DrMeghana Ghanti 
Address  Kaher Shri BM Kankanwadi Ayurveda Mahavidyalaya Shahpur Belagavi 
Type of Sponsor  Other [self] 
 
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 Meghana ghanti  KLE BMK Ayurveda Mahavidyalaya   KLE BMK Ayurveda Mahavidyalaya Shahpur Belagavi dravyaguna department OPD 3
Belgaum
KARNATAKA 
9108703306

meghanaghanti15@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethical committe for research on human subjects KAHER s Shri BM Kankanwadi Ayurveda Mahavidyalaya and KLE Ayurveda hospital Shahpur Belagavi  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:F419||Anxiety disorder, unspecified. Ayurveda Condition: KAMPAH/VEPATHUH, (2) ICD-10 Condition:G998||Other specified disorders of nervous system in diseases classified elsewhere. Ayurveda Condition: KAMPAH/VEPATHUH, (3) ICD-10 Condition:E059||Thyrotoxicosis, unspecified. Ayurveda Condition: KAMPAH/VEPATHUH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmDrugClassical(1) Medicine Name: Indravaruni Taila, Reference: Sharangadhara Samhita, Route: Oral, Dosage Form: Taila, Dose: 10(ml), Frequency: od, Bhaishajya Kal: Abhakta, Duration: 21 Days, anupAna/sahapAna: Yes(details: -milk), Additional Information: -
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  1 Individuals of either sex.
2 Patients between the age group of 18 to 80 years fulfilling the diagnostic
criteria of Kampa.
3 Patients presenting with tremors with all kinds of diseases (e.g.-
thyrotoxicosis, alcohol withdrawal, anxiety, Parkinson’s etc.) 
 
ExclusionCriteria 
Details  Pregnant or lactating women.
Patients diagnosed with malignancy 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
INDRAVARUNI (Colocynth Citrullus) is expected to be effective in improving
kampa ie tremors
 
Tremors assessed on 0th 11th and 21st day
 
 
Secondary Outcome  
Outcome  TimePoints 
Decrease in the grading of tremors  18 months 
 
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 3/ Phase 4 
Date of First Enrollment (India)   10/05/2024 
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="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   DISEASE REVIEW-
By definition tremors are involuntary, oscillatory movements resulting from alternating contraction and relaxation of muscles. Tremors are usually classified according to frequency, amplitude, position and the body part affected.
               Physiological tremors are fine, high frequency postural tremor occurring in hyperthyroidism, alcohol withdrawal and adverse effect of beta agonist bronchodilators.
                Essential tremor is the most common pathological tremor involving upper limbs (typically similar) head, voice6.
                 Parkinson’s disease causes slow, pill rolling tremor, worse at rest and reduces with voluntary movements.
Other involuntary movements include-
1.Dystonia- sustained muscle contractions, leading to twisting repetitive movements.
2.Chorea- brief, jerky, random movements.
3.Athetosis- slower, writhing movements
4.Ballism- violent flinging movements
5.Tics- repetitive, stereotyped movements can be briefly suppressed by the patient.
                  Gatradi chalanam – the one which produces shaking or movements in the body.
 Tremors or involuntary movements can be considered as Kampa according to ayurveda.
Acharya charaka has quoted Kampa as one of the nanatmaja vyadhi. Few other acharyas have quoted Kampa as vepathu. Kampa can be considered as a cardinal symptom of vataprakopa and pittakshaya. There is no separate samprapti told for Kampa, so in general samprapti of vata vyadhi8 is considered.
                                          1. Nidana sevana ( vata vardhaka ahara)
                                                     2. Rasa dhatu kshaya
                                                    3. Utarotta dhatu kshaya
                                           4. Vitiated vata travels throughout the body
       5.Vitiated vata impairs the Sneha guna in the srotas by its ruksha, sheeta and laghu guna
                    6.The vitiation of srotas by vata, impairs the motar functions of the body causing increase in the chala guna.
                                                                7. KAMPA
Kampavata can be considered as parkinsons disease. Acharya vagbhata has mentioned Kampa as the symptoms of vrudha avastha. Vrudhaavastha contributes for dhatukshaya which is the prime cause for vata prakopa and in turn responsible for the manifestation of Kampa.
       Hence, these specific vitiations of vatavaha srotas impair the body’s motor functions, leading to Kampa.
 
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