| CTRI Number |
CTRI/2021/12/038531 [Registered on: 09/12/2021] Trial Registered Prospectively |
| Last Modified On: |
05/09/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
To Evaluate the Effect of Padabhyanga with Ksheerabala Taila in Insomnia among Breast Cancer Survivors |
|
Scientific Title of Study
|
A Single Arm Open Labelled Study to Evaluate the Effect of Padabhyanga with Ksheerabala Taila in Insomnia among Breast Cancer Survivors |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Veena L |
| Designation |
PG Scholar |
| Affiliation |
Amrita School of Ayurveda |
| Address |
Amrita School of Ayurveda, Amritapuri
Kollam
Kerala
Kollam KERALA 690525 India |
| Phone |
08075949251 |
| Fax |
|
| Email |
thampiveena@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Anusree Dileep |
| Designation |
Associate Professor |
| Affiliation |
Amrita School of Ayurveda |
| Address |
Amrita School of Ayurveda
Amritapuri
Kollam
Kerala
Kollam KERALA 690525 India |
| Phone |
09446055144 |
| Fax |
|
| Email |
dranusree15@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Anusree Dileep |
| Designation |
Associate Professor |
| Affiliation |
Amrita School of Ayurveda |
| Address |
Amrita School of AYurveda
Amritapuri
Kollam
Kerala Amrita School of AYurveda
Amritapuri
Kollam
Kerala Kollam KERALA 690525 India |
| Phone |
09446055144 |
| Fax |
09446055144 |
| Email |
dranusree15@gmail.com |
|
|
Source of Monetary or Material Support
|
| Amrita School of Ayurveda
Amritapuri
Clappana(PO) Kollam |
|
|
Primary Sponsor
|
| Name |
Dr Veena L |
| Address |
PG Scholar
Amrita School of Ayurveda
Kollam |
| 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 Veena L |
Amrita School of Ayurveda |
Amrita School of Ayurveda Department of Swasthavritta
Clappana(PO) Vallikavu pin 690525 kollam
Kerala Kollam KERALA |
08075949251
thampiveena@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Amrita Institute of Medical Sciences |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:C00-D49||Neoplasms. Ayurveda Condition: Nidra nasham, |
|
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Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | EkA~gga, à¤à¤•ांग | (Procedure Reference: Susruta Samhita chikitsa Sthana, Procedure details: Abhyanga should be done separately on each foot for 15 minutes at evening for a period of one month) (1) Medicine Name: Ksheerabala Taila, Reference: Sahasrayogam, Route: Topical, Dosage Form: Taila, Dose: 30(ml), Frequency: od, Duration: 1 Months |
|
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Female |
| Details |
Breast cancer survivors (within 5 years after
diagnosis) who have received either
chemotherapy and/or who have undergone surgery
Patient aged between 40-70 years
Patient having Athens Insomnia Scale score ≥ 6 |
|
| ExclusionCriteria |
| Details |
Patient diagnosed with severe medical illness
including cardiovascular, liver or kidney
dysfunction
Patient who are taking antidepressants or
antipsychotic drugs |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Athens Insomnia Scale Score |
Athens Insomnia Scale Score will be assessed on first day before trial and after one month of treatment |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
Nil |
|
|
Target Sample Size
|
Total Sample Size="22" Sample Size from India="22"
Final Enrollment numbers achieved (Total)= "22"
Final Enrollment numbers achieved (India)="22" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
13/12/2021 |
| 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="1" Months="6" 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)?
Response - NO
|
Brief Summary
Modification(s)
|
Insomnia is common in breast cancer survivors with an estimate ranging from 19.2%-73%. Insomnia is characterized by complaints of difficulty initiating/ maintaining sleep/ non- restorative sleep which can last for at least one month. Insomnia can deplete not only energy level and mood, but also health, work performance and quality of life.Treatment protocols for insomnia is mainly Hypnotic drugs and cognitive behavioral therapy (CBT). Hypnotic drugs may cause serious side effects such as suicidal thinking. Sedatives and hypnotics lead to CNS toxicities, rebound sleep impairment after discontinuation and ultimately do not cure sleep problem. Lack of CBT therapist and it is not suitable for patients with learning disabilities as it requires structured sessions. Also CBT focus on the patient’s capacity to change themselves. According to Ayurveda, Padabhyanga is a cheap, safe and easy external treatment procedure . According to Susruta, Padabhyanga is Nidrakara, provides wellness to the body and sense organs, relieves fatigue.Literature review shows that by massaging with luke warm oil, tactile and mechano receptors get stimulated and thus a kinetic energy being developed which leads to the activation of axons at surface level, thereby producing neurotransmitters serotonin and nor epinephrine which regulates sleep. Other findings from the literature review include padabhyanga increases the intensity of brain wave (delta wave) and decreases the level of adrenaline and cortisol, thereby regulates sleep.By doing padabhyanga Ajna chakra and Sahasrara chakra getting stimulated and activating the hypothalamus functioning normally. It influences sleep rhythm & behavioral pattern and give nourishment to the sensory organs · 22 breast cancer survivors should be done according to symptoms of anidra and AIS scale · After taking the informed consent, the procedure of padabhyanga will be explained and the bystander will be given proper training · The patient is advised to continue padabhyanga for a period of one month. · Abhyanga should be done separately on each foot for 15 minutes at evening · Patient is advised to take rest for 10 minutes after abhyanga · Patient will be given pamphlet containing the detailed procedure & ksheerabala taila for 15 days . · Patient will be advised to report, on 15th day and patient compliance will be enquired and ksheerabala taila for next 15 days will be given. · Assessment of symptoms and AIS scale will be done on 30th day and follow up after 15 days. Observations and results Improvement was observed in all domains of Athens Insomnia Scale score, and was found to be statistically significant. Marked reduction was found in total Athens Insomnia Scale score and Athens Insomnia Scale Severity Index and was found to be statistically significant. So, overall the padabhyanga with ksheerabala taila is effective in managing insomnia among breast cancer survivors
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