| 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
|
|
|
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
|
|
|
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
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (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. |