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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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:C00-D49||Neoplasms. Ayurveda Condition: Nidra nasham,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmProcedure-EkA~gga, एकांग  (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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