| CTRI Number |
CTRI/2024/06/068545 [Registered on: 06/06/2024] Trial Registered Prospectively |
| Last Modified On: |
05/06/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To compare the effect of Shirodhara with Takra and Jatamansi oil in two group of 15 patients in the management of Anidra w.s.r Primary Insomnia |
|
Scientific Title of Study
|
A comparative study to evaluate the efficacy of Shirodhara in the form of Takradhara and Snehadhara with Jatamansi oil in the management of Anidraw.s.r. Primary 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 |
Dr Amrita Kumari |
| Designation |
MD (Ay.) Scholar (Dept. Of Panchkarma) |
| Affiliation |
Govt. Ayurvedic Medical College and Hospital |
| Address |
Dept. of Panchkarma, Govt. Ayurvedic Medical College and Hospital, Near Buddha Murti, kadamkuan
Near Buddha Murti, kadamkuan, Patna- 800003
Patna
BIHAR
800003
India |
| Phone |
9473118224 |
| Fax |
|
| Email |
anitakumarigach@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Akhilesh Prasad Singh |
| Designation |
HOD & Asso. Prof. Dept. of Panchkarma |
| Affiliation |
Govt. Ayurvedic Medical College and Hospital |
| Address |
Dept. of Panchkarma, Govt. Ayurvedic Medical College and Hospital, Near Buddha Murti, kadamkuan
Near Buddha Murti, kadamkuan
Patna
BIHAR
800003
India |
| Phone |
8002680973 |
| Fax |
|
| Email |
drapsinghpatna@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Akhilesh Prasad Singh |
| Designation |
HOD & Asso. Prof. Dept. of Panchkarma |
| Affiliation |
Govt. Ayurvedic Medical College and Hospital |
| Address |
Dept. of Panchkarma, Govt. Ayurvedic Medical College and Hospital, Near Buddha Murti, kadamkuan
Near Buddha Murti, kadamkuan
Patna
BIHAR
800003
India |
| Phone |
8002680973 |
| Fax |
|
| Email |
drapsinghpatna@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government Ayurvedic College and Hospital, Near Buddha Murti, kadamkuan, Patna, Bihar- 800003, India |
|
|
Primary Sponsor
|
| Name |
Dr Amrita Kumari |
| Address |
Dept. of Panchkarma, Govt. Ayurvedic Medical College and Hospital, Near Buddha Murti, kadamkuan, Patna, Bihar-800003, India |
| 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 Amrita Kumari |
Govt. ayurvedic medical college and hospital |
dept. of panchkarma, OPd. no. 11, GACH, Patna
Patna
BIHAR |
9473118224
anitakumarigach@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee (IEC) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:G470||Insomnia. Ayurveda Condition: NIDRANASAH/ASVAPNAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | SiraHsekaH, शिरःसेकः | (Procedure Reference: Susruta Samhita Uttartantra 26, Procedure details: In Shirodhara/Sirahseka Purvakarma is related with preparation of patients & materials required. Posture of patients for shirodhara is supine position & dharapatra will be fixed 4 anguli above the forehead. Shirodhara will be done in the morning on empty stomach after proper massage. Then the prepared takra will be kept in the dharapatra & poured continuously on the centre of forehead of the patient for 30 mins.)
(1) Medicine Name: Takra, Reference: Dharakalp, Route: Topical, Dosage Form: Kwatha/Kashaya, Dose: 3000(ml), Frequency: od, Duration: 14 Days | | 2 | Comparator Arm | Procedure | - | SiraHsekaH, शिरःसेकः | (Procedure Reference: Procedure Reference: Susruta Samhita Uttartantra 26, Procedure details: In Shirodhara Purvakarma is related with preparation of patients & materials required. Posture of patients for shirodhara is supine position and dharapatra will be fixed 4 anguli above the forehead. Shirodhara will be done in the morning on empty stomach after proper massage. Then the prepared takra will be kept in the dharapatra and poured continuously on the centre of forehead of the patient for 30 mins.)
(1) Medicine Name: Jatamansi Tail, Reference: Dharakalp, Route: Topical, Dosage Form: Taila, Dose: 3000(ml), Frequency: od, Duration: 14 Days |
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients presenting with complaints of Reduction of sleep time
2. Difficulty in initiation of sleep, Patients fulfilling AIS scoring i.e., greater than 6 or equals to 6.
3. Wakefulness during normal sleep.
4. Either any of the above or all of them for the duration of 3 months or more.
5. Patient of either sex in the age group of 20 – 70 years.
6. Willing to give informed consent. |
|
| ExclusionCriteria |
| Details |
1. Disease like diabetes mellitus, cancer, AIDS, LVH, T.B. and other systemic disorder which leads fatal condition for patient.
2. Patient below 20 or above 70 years
3. Pregnant women and lactating mothers
4. Patient with stroke, haemorrhagic disorders, epilepsy or any other serious psychotic disorder
5. Patient with alcohol dependency or drug dependency.
6. Subjects who were having night jobs
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
In 2 groups results of changes in signs and symptoms before and after treatment shall be observed and the same shall be recorded in the proforma of the case sheet prepared for the study.
 Athens Insomnia Scale (AIS)
 Sleep induction (time it takes you to fall asleep after turning-off the lights)
 Awakenings during the night.
 Final awakening earlier than desired.
 Total sleep duration,
 Overall quality of sleep (no matter how long you slept).
 Sense of well-being during the day.
 Functioning (physical and mental) during the day.
 Sleepiness during the day. |
28 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Yawning, lethargic, generalised body ache, anxious, headache, heaviness of head, heaviness of eyes, giddiness, Anorexia will be assessed. |
28 days |
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
26/06/2024 |
| 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="0"
Months="8"
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 - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identification.
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Clinical Study Report
- Who will be able to view these files?
Response - Anyone
- For what types of analyses will this data be available?
Response - Any purpose.
- By what mechanism will data be made available?
Response - Proposals should be directed to [anitakumarigach@gmail.com].
- For how long will this data be available start date provided 26-06-2025 and end date provided 26-06-2031?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
This study is a randomizes, open, parallel group, interventional, prospective trial for comparing the effect of shirodhara in a group of 15 patients with Takra and another group of 15 patients with Jatamansi tail, which will be given for 14 days once daily at department of Panchkarma at Govt. Ayurvedic Medical College and Hospital at PATNA, Bihar and post intervention followup will be done after 14 days for the total duration of study of 28 days. |