| CTRI Number |
CTRI/2012/05/002671 [Registered on: 21/05/2012] Trial Registered Retrospectively |
| Last Modified On: |
12/04/2017 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A clinical trial to study the effect of Head Massage with NRCCO Oil in Patients Suffering from Mild to Moderate Anxiety and Stress |
|
Scientific Title of Study
|
An Open Labeled, Prospective, Clinical Study to Evaluate Efficacy and Safety of Head Massage with NRCCO OIL in Patients Suffering from Mild to Moderate Anxiety and Stress |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| EM/NRCCO OIL/03/2011 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Meenakshi Revedkar |
| Designation |
Associate Professor |
| Affiliation |
R. A. Podar Medical (Ay) College & M. A. Podar Hospital,Dr. Annie Besant Road, Worli, Mumbai |
| Address |
Dept of Kayachikitsa
R. A. Podar Medical (Ay) College & M. A. Podar Hospital,Dr. Annie Besant Road, Worli, Mumbai
Mumbai
MAHARASHTRA
400018
India |
| Phone |
|
| Fax |
|
| Email |
meenakshirewadkar@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Meenakshi Revedkar |
| Designation |
Associate Professor |
| Affiliation |
|
| Address |
Dept of Kayachikitsa
R. A. Podar Medical (Ay) College & M. A. Podar Hospital,Dr. Annie Besant Road, Worli, Mumbai
Mumbai
MAHARASHTRA
400018
India |
| Phone |
|
| Fax |
|
| Email |
meenakshirewadkar@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Meenakshi Revedkar |
| Designation |
Associate Professor |
| Affiliation |
|
| Address |
Dept of Kayachikitsa
R. A. Podar Medical (Ay) College & M. A. Podar Hospital,Dr. Annie Besant Road, Worli, Mumbai
Mumbai
MAHARASHTRA
400018
India |
| Phone |
|
| Fax |
|
| Email |
meenakshirewadkar@gmail.com |
|
|
Source of Monetary or Material Support
|
| Emami Limited
5th Floor, Golden Chambers,
New Link Road, Andheri (W),
Mumbai -400053, India |
|
|
Primary Sponsor
|
| Name |
Emami Limited |
| Address |
5th Floor, Golden Chambers, New Link Road, Andheri (W), Mumbai -400053, India |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
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 Meenakshi Revadkar |
Department of Kayachikitsa |
R. A. Podar Medical (Ay) College,& M. A. Podar Hospital,Dr. Annie Besant Road, Worli, Mumbai 18
Mumbai
MAHARASHTRA |
9421291561
meenakshirewadkar@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee of R.A. Podar Medical College (Ayu) & M.A. Podar Hospital, Worli, Mumbai |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Stress and Anxiety, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
| Intervention |
NRCCO |
Sr. No. Official name of Ingredients in Sanskrit/Hindi/Common Botanical name Quantity (mg) Each 100 ml cont.
1 Hriber Povania odorata 0.0075
2 Bhringaraj Eclipta alba 0.0075
3 Latakasturi Hibiscus abelmoschus 0.0300
4 Sailaja Parmelia perlata 0.0300
5 Nagarmoyha Cyperus scariosus 0.0300
6 Karchoor Curcuma zedoaria 0.0300
7 Japa Pushpa Hibiscus rosa sinensis 0.0375
8 Kshirkakoli Linium polyphyllum 0.0150
9 Manduaparni Centella asiatica 0.0150
10 Amla Emblica officinalis 0.1500
11 Pudina ka phool Mentha arvensis 2.5000
12 Pudina ka tel Mentha arvensis 0.5000
13 Karpoor Cinnamomum camphora 0.5000
14 Base containing Colour, Mineral oil, vegetable oil and anti-oxidant q.s to 100
Dosage & Treatment Duration:
Study subjects will be advised to do head massage by using 15 ml NRCCO Oil in the morning (30 minutes before bath) and in the evening (30 minutes before bedtime) daily for 28 days.
|
|
|
Inclusion Criteria
|
| Age From |
23.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Subjects meeting all of the following criteria will be included to the trial-
1)Subjects suffering from mild to moderate anxiety (who achieve scores between 18 and 24 points on the Hamilton Scale for Anxiety)
2)Subject having age 20 to 65 years, both inclusive.
3)Subjects of female gender or a non-pregnant, non-lactating females, at least six weeks postpartum. A urine pregnancy test is required for all female subjects unless subject has had a hysterectomy, tubal ligation, or is > 2 years postmenopausal.
4)Subjects willing to follow the procedures as per the study protocol and voluntarily sign an informed consent form.
|
|
| ExclusionCriteria |
| Details |
1)Subjects suffering from severe depression, schizophrenia, diabetes mellitus, heart disease, HIV/AIDS, kidney and liver diseases will not be recruited in the trial.
2)Subjects having addiction to any drug, including alcohol will not be recruited in the trial.
3)Subjects who are using any medication such as anxiolytic, anti-stress medication and under psychotherapy will not be recruited in the trial
4)Subjects on any other medications that could interfere with the effect of the drug under study will not be recruited in the study.
5)In addition, subject should have ECG not demonstrating any signs of uncontrolled arrhythmia / acute ischemia.
6)Subjects having a chronic, contagious infectious disease, such as active tuberculosis, Hepatitis B or C, or HIV.
7)Subjects having active metabolic or gastrointestinal diseases that may interfere with nutrient absorption, metabolism, or excretion,
8)Use of any other investigational drug within 1 month prior to randomization
9)Known hypersensitivity to ingredients used in study drug
10)Pregnant and Lactating females. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Mean change from baseline visit to week 4 in Hamilton Rating Scale for Anxiety (HAM-A) Total Score |
28 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Mean change from baseline visit to week 4 in Global assessment for overall improvement assessment by the Investigator
2. Mean change from baseline visit to week 4 in Global assessment for overall improvement assessment by the subject
3. Mean change from baseline visit to week 4 in overall Quality Of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q)
4. Tolerability of study drugs by assessing the incidence of adverse events (AEs) and discontinuation due to the AEs
|
28 days |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
10/01/2012 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="8"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
Modification(s)
|
Subjects suffering from anxiety and stress, attending outpatient clinic at R. A. Podar Hospital, Worli, Mumbai-18 will be screened for eligibility criteria. Considering 20% dropout rate, 36 subjects will be recruited in the trial to get 30 evaluable cases. On screening visit, a written informed consent will be obtained from subjects for their participation in the study. Subject’s history will be recorded and his/her physical examinations will be done. Subject will be assessed for severity of Anxiety on Hamilton Anxiety Rating Scale (HAM-A). If Subject’s score is between 18 and 24 points on HAM-A, then subject will be considered eligible for recruitment. On baseline visit, subject will be recruited in the study if he/she meets all the inclusion criteria. Subject will be asked to come to hospital for follow up on every week after baseline visit till the completion of the study (Week 4). At baseline visit and at every follow up visit (except last follow up visit), subjects will be given 2 bottles each containing 150 ml of NRCCO Oil (210 ml for 7 days and 90 ml for use if follow up is delayed maximum by 3 days). Subjects will be advised to apply sufficient quantity of NRCCO Oil on scalp and thereafter head massage for 10 minutes. Subjects will be instructed to use NRCCO Oil for head massage two times daily i.e in the morning (30 minutes before bath) and in the evening (30 minutes before bedtime) . On every follow up visit, subjects will undergo general and systemic examinations and assessment of severity of anxiety on HAM-A scale. Subject’s global evaluation for overall improvement and Investigator’s global evaluation for overall improvement will be done on every follow–up visit till the completion of the study. Tolerability of the trial drug will be assessed by the investigator and by the patient at the end of the trial. All the subjects will be closely monitored for any Adverse Events starting from baseline visit till the end of the study visit.
Summary of Results: The present study on NRCCO concludes that head massage with NRCCO helps significantly in reducing the symptoms of stress and anxiety as measured on HAMA scale. The common symptoms of stress and anxiety like insomnia, tension, fear, depressed mood, headache were relieved significantly by regular head massage with NRCCO for 28 days. A significant reduction in the symptoms was observed with 7 days of head massage with oil. The improvement in symptoms continued and at the end of the trial i.e. 28 days. It can thus be concluded that head massage with NRCCO can prove to be a useful remedy in the management of stress and anxiety. |