| CTRI Number |
CTRI/2013/07/003837 [Registered on: 25/07/2013] Trial Registered Retrospectively |
| Last Modified On: |
24/03/2013 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Ayurvedic medicated MADHUKADI oil SHIROPICHU(scalp application) AND PIPPALIMULA CHURNA orally IN THE MANAGEMENT OF Insomnia |
|
Scientific Title of Study
|
A CLINICO COMPARATIVE STUDY OF MADHUKADI TAIL SHIROPICHU AND PIPPALIMULA CHURNA IN THE MANAGEMENT OF ANIDRA W.S.R. TO INSOMNIA |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
sunil babubhai hapaliya |
| Designation |
MD second year |
| Affiliation |
Institute of Post graduation Teaching and Research in Ayurveda |
| Address |
opd no.20
Department of Panchkarma
IPGT RA
Gujarat Ayurveda University
Jamnagar
opd no.20
Department of Panchkarma
IPGT RA
Gujarat Ayurveda University
Jamnagar
Jamnagar
GUJARAT
361008
India |
| Phone |
9033302353 |
| Fax |
|
| Email |
sunilhapaliya@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Anup Thakar |
| Designation |
Associate professor and HOD |
| Affiliation |
Institute of Post graduation Teaching and Research in Ayurveda |
| Address |
opd no.20
Department of Panchkarma
IPGT RA
Gujarat Ayurveda University
Jamnagar
opd no.20
Department of Panchkarma
IPGT RA
Gujarat Ayurveda University
Jamnagar
Jamnagar
GUJARAT
361008
India |
| Phone |
9427776660 |
| Fax |
|
| Email |
anup_thakar@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Anup Thakar |
| Designation |
Associate professor and HOD |
| Affiliation |
Institute of Post graduation Teaching and Research in Ayurveda |
| Address |
opd no.20
Department of Panchkarma
IPGT RA
Gujarat Ayurveda University
Jamnagar
opd no.20
Department of Panchkarma
IPGT RA
Gujarat Ayurveda University
Jamnagar
GUJARAT
361008
India |
| Phone |
9427776660 |
| Fax |
|
| Email |
anup_thakar@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Institute of Post graduation Teaching and Research in Ayurveda |
|
|
Primary Sponsor
|
| Name |
Institute of Post graduation Teaching and Research in Ayurveda |
| Address |
Gujarat Ayurveda University
Jamnagar |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| Sunil Hapaliya |
Institute of post graduation teaching and research in Ayurveda |
OPD no 20
Department of Panchkarma
IPGT RA
GAU
Jamnagar
GUJARAT |
9033302353
sunilhapaliya@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics commitee of IPGT RA |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Insomnia, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Pipplimula Churna with Guda (jaggery) |
1 gm pippalimula churna twice a day with 2 gm guda (jaggery)upto 4 weeks |
| Intervention |
Siropichu with Madhukadi Tail |
local application over scalp for 60 mins upto 2 weeks |
|
|
Inclusion Criteria
|
| Age From |
16.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients suffering from following type of disturbed sleep pattern.
(a) Sleep onset insomnia (Difficulty taking sleep at the beginning of the night)
(b) Sleep maintenance insomnia (Difficulty maintain the sleep)
(c) Nocturnal awakenings (Difficulty to retuning to sleep after awakening in the middle of the night or wakening early in the morning)
(d) Rebound insomnia (Patients who has developed dependence to sedatives)
(e) Circadian rhythm disorders (Sleeping pattern changes)
(f) Patients having insomnia more than 2 weeks, less than 6 months
2. Patients of insomnia with mild hypertension, mild depression and anxiety disorders without any complaints of any other major diseases.
|
|
| ExclusionCriteria |
| Details |
1. Patients suffering from fatal familial insomnia.
2. Insomnia with major psychiatric illness like Schizophrenia depressive psychosis, Epilepsy, etc.
3. Patients having advanced chronic illness like Bronchial asthma, Diabetes mellitus, malignancy, Liver cirrhosis, chronic renal failure.
4. Patients with alcohol or drug dependency, will be excluded.
5. Patients having acute illness like cardiovascular accidents, myocardial infarction, chronic obstructive pulmonary disease.
|
|
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Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| lightness of body, freshness of mine |
upto 3 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| relief in body ache, eyestrain and drowsiness |
upto 3 weeks |
|
|
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 1/ Phase 2 |
|
Date of First Enrollment (India)
|
04/03/2013 |
| 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="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
not yet published |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This is a randomized parallel group trial on insomnia with ayurvedic medicated madhukadi tail local application over scalp for 60 mins. in Group A and oral medicine-1 gm Pippalimula churna with 2 gm guda in Group B, Madhukadi taila described in sushruta samhita. Pippali-guda reference from Bhisajya ratnavali. Hamilton anxiety raring scale and GSR biofeedback machine is used to assess the effect.
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