| CTRI Number |
CTRI/2024/10/075336 [Registered on: 15/10/2024] Trial Registered Prospectively |
| Last Modified On: |
24/09/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A Comparative Clinical Study To Evaluate The Efficacy of Panchakarma Procedure Shirodhara And Abhyanga In Insomnia. |
|
Scientific Title of Study
|
A Comparative Clinical Study Of Shirodhara And Abhyanga With Tila Taila In Nidranasha w.s.r To Insomnia. |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Rutuja Rangrao Darekar |
| Designation |
PG Scholar MD Panchakarma |
| Affiliation |
MES ayurveda mahavidyalay and research Center |
| Address |
Second floor , Panchakarma Department, PG section, MES Ayurveda Mahavidyalay Ghanekunth Lote Khed Ratnagiri.
Ratnagiri
MAHARASHTRA
415722
India |
| Phone |
9545476122 |
| Fax |
|
| Email |
rutujadarekar121@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Vd Vrushali swami |
| Designation |
HOD & Professor MD Panchakarma |
| Affiliation |
MES ayurveda mahavidyalay and research center |
| Address |
Second Floor, Panchakarma Department , PG Section , MES Ayurveda Mahavidyalay, Ghanekunth lote, Khed Ratnagiri.
Ratnagiri
MAHARASHTRA
415722
India |
| Phone |
9422856123 |
| Fax |
|
| Email |
vrushaliswami2009@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Rutuja Rangrao Darekar |
| Designation |
PG Scholar MD Panchakarma |
| Affiliation |
MES ayurveda mahavidyalaya and research centre . |
| Address |
Second floor, Panchakarma Department , MES Ayurveda Mahavidyalay, Ghanekunth lote, khed Ratnagiri.
Ratnagiri
MAHARASHTRA
415722
India |
| Phone |
9545476122 |
| Fax |
|
| Email |
rutujadarekar121@gmail.com |
|
|
Source of Monetary or Material Support
|
| MES Ayurveda Mahavidyalay & Attached Parshuram Hospital & Research Center , Ghanekunth Lote, Khed, Ratnagiri Maharashtra India -415722 |
|
|
Primary Sponsor
|
| Name |
vdrutuja rangrao darekar |
| Address |
MES Ayurveda Mahavidyalay Ghanekunth , Lote, Khed, Ratnagiri. Maharashtra India 415722 |
| 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 |
| Rutuja rangrao Darekar |
Prashuram hospital and research centre |
Panchakarma opd ,Ghanekuntha lote , khed ratnagiri .
Ratnagiri
MAHARASHTRA |
09545476122
rutujadarekar121@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| MES ayurved mahavidyalaya Ethics committiee |
Approved |
|
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Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:G908||Other disorders of autonomic nervous system. Ayurveda Condition: NIDRANASAH/ASVAPNAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | aBya~ggaH, अà¤à¥à¤¯à¤‚ग | (Procedure Reference: ashtanga Hridaya sutra 2 , Procedure details: Ask patient to sit on abhyanga table with leg extended . abhyanga will be done in 7 different positions . massage will be done in each position for 5 mins .duration 35 mins for 7 days )
(1) Medicine Name: Tila , Reference: Bhavprakasha purvardha 6/2-7, Route: Topical, Dosage Form: Taila, Dose: 150(ml), Frequency: od, Duration: 7 Days | | 2 | Intervention Arm | Procedure | - | Sirodhara | (Procedure Reference: sushruta uttartantra 26/12, Procedure details: Patient should lie comfortably in supine position on dharatable. Height of shirodharapatra will be fixed such a that oil will fall from a height of 4 angula in a continuous uniform oscillating thick flow covering entire forehead .Tila taila will be heated just above body temperature . collect tila taila in collecting vessels for reuse .temperature will be maintained throughout procedure .)
(1) Medicine Name: tila , Reference: Bhavprakasha purvardha 6/2-7, Route: Topical, Dosage Form: Taila, Dose: 1500(ml), Frequency: od, Duration: 7 Days |
|
|
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Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients fulfilling diagnostic criteria of Nidranasha and Insomnia.
Age group from 20 yrs To 60 yr .
Patients irrespective of gender, religion, economic status education occupation. |
|
| ExclusionCriteria |
| Details |
Patients who are mentioned as Shirodhara and abhyanga anarha in classical text.
Age group below 20 yrs and above 60 Yrs.
Patients with stroke, hemorrhagic disorder,
Epilepsy and other psychotic disorder.
Patients is on medication that can cause sedation, Chronic alcoholism , Drug dependency .
Rash, Cut, Abrasion , Injury .
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To study Difference between efficacy of shirodhara and abhyanga to reduce symptoms of nidranasha . |
7 days intervention with follow up on 7th , 14th ,21th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To study if there is no difference between efficacy of shirodhara and abhyanga to reduce symptoms of nidranasha . |
7 days of intervention with follow up on 7th,14th,21th day . |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
24/10/2024 |
| 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 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
|
Title A comparative clinical study of shirodhara and abhyanga with tila taila in nidranasha w.s.r to insomnia .
Primary research question Is there any difference between efficacy of shirodhara and abhyanga with tila taila in nidranasha ?
Primary Hypothesis There is significant difference between efficacy of shirodhara and abhyanga with tila taila in nidranasha .
Null Hypothesis There is no difference between efficacy of shirodhara and abhyanga with tila taila in nidranasha .
Primary objective To compare shirodhara and abhyanga with tila taila in nidranasha .
Secondary objective To study literature aspect of shirodhara ,abhyanga , nidranasha and insomnia . To prepare methodology and sop for clinical trial . To conduct clinical trial To assess efficacy after result .
Methodology Study design - Open label randomized comparative clinical trial . Study centre- Hospital of our institution . study population - Patients having classical sign and symptoms of nidranasha w.s.r to insomnia . Overall duration of study -18 months Sample size - 30 in each group , group A and B Total 60 .
Inclusion criteria - Patients fulfilling the diagnostic criteria of nidranasha and insomnia . Age group -20 to 60 years Gender - both male and female Patients irrespective of religion , economical status , education and occupation etc.
Exclusion criteria - Patients who are mentioned shirodhara anarha and abhyanga anarha in classical text. age group below 20 and above 60 yrs . Patients with stroke ,heamorrhagic disorder , epilepsy and psychotic disorder . Patients is on medication that cause sedation , chronic alcoholism , drug dependent . Rashes, cut ,abrasion ,injury .
Withdrawal criteria - Sudden increase in sign and symptoms . Patients want to discontinue treatment despite of giving consent . Patients who will not following instruction and follow ups of treatment . Patients who will not continuous for 7 days of treatment ..
Treatment administration Grouping group A Intervention shirodhara Drug Tila taila Quantity 1500 ml Duration 7 days Time for Procedure 45 mins Period of changing drug Tila taila change every 3 days Temperature lukewarm follow up After 7.14.21. days
Grouping Group B Intervention Abhyanga Drug Tila taila Quantity 150 ml Duration 7 days Time of procedure 35 mins Period of changing drug Fresh each day Temperature lukewarm Follow up After 7,14,21 days
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