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CTRI Number  CTRI/2025/01/079781 [Registered on: 29/01/2025] Trial Registered Prospectively
Last Modified On: 25/01/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   TO KNOW THE EFFICACY OF FOOT REFLEXOLOGY IN THE MANAGEMENT OF INSOMNIA. 
Scientific Title of Study   A Randomized Open-Labelled Controlled Clinical Study To Evaluate The Efficacy Of Foot Reflexology In The Management Of Anidra With Special Reference To 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 Namrata 
Designation  PG Scholar 
Affiliation  sri sri college of ayurvedic science and research hospital 
Address  Room NO.8,Panchakarma OPD, Sri Sri College Of Ayurvedic Science and Research Hospital, 21st K.M. Kanakapura Road , Udayapura.

Bangalore
KARNATAKA
560082
India 
Phone  8618550130  
Fax    
Email  namratampatil1998@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Ganesh Puttur 
Designation  Professor and HOD 
Affiliation  sri sri college of ayurvedic science and research hospital 
Address  Room NO.8,Panchakarma OPD, Sri Sri College Of Ayurvedic Science and Research Hospital, 21st K.M. Kanakapura Road , Udayapura.

Bangalore
KARNATAKA
560082
India 
Phone  9538176059  
Fax    
Email  drganeshputtur@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Ganesh Puttur 
Designation  Professor and HOD 
Affiliation  sri sri college of ayurvedic science and research hospital 
Address  Room NO.8,Panchakarma OPD, Sri Sri College Of Ayurvedic Science and Research Hospital, 21st K.M. Kanakapura Road , Udayapura.

Bangalore
KARNATAKA
560082
India 
Phone  9538176059  
Fax    
Email  drganeshputtur@gmail.com  
 
Source of Monetary or Material Support  
Sri Sri College of Ayurvedic Science and Research Hospital, 21st K.M. Kanakapura Road, Udayapura. Bangalore KARNATAKA 560082 India 
 
Primary Sponsor  
Name  Dr Namrata 
Address  Sri Sri College of Ayurvedic Science and Research Hospital, 21st K.M. Kanakapura Road, Udayapura. Bangalore KARNATAKA 560082 India 
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 Namrata  Sri Sri College of Ayurvedic Science and Research Hospital Banglore  Room no-8, Panchakarma OPD, Sri Sri College of Ayurvedic science and Research Hospital, 21st K.M. Kanakapura Road, Udayapura. Bangalore KARNATAKA
Bangalore
KARNATAKA 
8618550130

namratampatil1998@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
SRI SRI INSTITUTIONAL ETHICAL COMMITTEE  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:F510||Insomnia not due to a substance orknown physiological condition. Ayurveda Condition: NIDRANASAH/ASVAPNAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmProcedure-foot reflexology (Procedure Reference: Kunz B, Kunz K. Complete guide to reflexology for life., Procedure details: Foot Reflexology is a therapy based on the principle that specific areas or "reflex points" on the feet correspond to different organs, glands, & systems within the body. By applying pressure to these reflex points, reflexology aims to promote relaxation, improve circulation, sleep & support the body’s natural healing processes.)
2Comparator ArmProcedure-Pada abhyanga (Procedure Reference: Panchakarma Illustrated Book by Shrinivasa Acharya G , Procedure details: PRADHAN KARMA - Taila will be heated on a water bath approximately up to 40°C. This warm oil was smeared to the feet both in its plantar & dorsal aspects up to ankle. Following this, massage was done by moving palms in distinct directions. It include following steps. Linear manoeuvre on the foot Linear manoeuvre on the sides of the foot Linear manoeuvre on the dorsum of foot Thumb poking on the soles Linear manoeuvre on the soles Circular manoeuvre on the pads To & fro manoeuvre on the soles Linear & circular massage on toes Linear massage on web spaces DURATION - 10 minutes )
(1) Medicine Name: Ksheerabala taila, Reference: Ashtanga Hrdaya, Route: Topical, Dosage Form: Bindu/ Drops/ Spray (Karna/ Nasa/ Netra/ Mukha), Dose: 20(ml), Frequency: od, Duration: 7 Days
 
Inclusion Criteria  
Age From  21.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Subjects between the age group of 21 – 60 years, irrespective of their gender, religion, occupation, and socioeconomic status.
Subjects with insomnia features as mentioned in DSM-5-TR Diagnostic Criteria of Primary Insomnia.
Subjects fit for Paadabhyanga and Foot reflexology.
Subjects who are willing to give written consent for the treatment.
 
 
ExclusionCriteria 
Details   
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Alternation 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Significant decrease in the symptoms of Anidra w.s.r to Primary insomnia when assessed by subjective and objective parameters.
Significant differences would be noted between Paadabhyanga with Ksheerabala Taila and Foot reflexology in Anidra when assessed by subjective and objective parameters.
 
0th DAY, 8th DAY, 15th DAY .
 
 
Secondary Outcome  
Outcome  TimePoints 
Generation of in-depth analysed data on the different aspect of the disease & procedure.
Generation of data on possible unexpected/adverse drug reactions or events.
 
NIL 
 
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   Phase 3 
Date of First Enrollment (India)   28/02/2025 
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 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 - NO
Brief Summary  

Nidra is one among the Trayopastambha,[1] i.e., three pillars of life; any disturbance in it hampers the quality of life. Sleep is the fundamental human need and a crucial component of both physical and mental health. It is vital for restoring energy consumed during the day and plays a key role in maintaining metabolic and endocrine functions, as well as improving cognitive functions like memory etc.[2]According to Acharya Vagbhata, Nidra furnishes Sukha, provides Pushti, Bala, Vrishata, Jnana, and Jeevana to Purusha. On the contrary, Anidra causes Dukha, Karshya, Balahrasa, Kleebata, Ajnana, and Marana.[3] Thus, Anidra  may hamper the equilibrium of the Tridoshas leading to severe derangement in Dhatus. In contemporary science, due to the close resemblance in the Lakshanas, Anidra can be correlated with  insomnia.

The American Academy of Sleep Medicine defines insomnia as unsatisfactory sleep that impacts daytime functioning.[4] Insomnia disorder is highly prevalent in the general population, with estimates of 10% among adults, among them 2-6 % use medications to aid sleep.[5] Another Indian study identified 15.4% prevalence of primary insomnia.[6] A study among corporate employees in India showed a prevalence of insomnia in 13.8% of participants.[7] Insomnia is associated with increased morbidity and mortality caused by cardiovascular diseases and psychiatric disorders and has other major public health and social consequences, such as accidents and absenteeism.[8] In developing countries like India the incidence of insomnia is increasing even in people not suffering from co morbid chronic physical illness.

The Modern medical science is still not having a definite treatment for insomnia. Present treatment includes cognitive behavioural therapy (CBT), use of antihistamines, sedative-hypnotics like benzodiazepines, use of anticonvulsants, antipsychotics, barbiturates and non hypnotic benzodiazepines. Many of these medications involve a significant level of risk. Most sedative and hypnotic drugs produce a dose-dependent depression of central nervous system function. The use of benzodiazepines produces central nervous depression including drowsiness, impaired motor coordination, confusion, memory loss, blurred vision, hallucinations and paradoxical reactions.[9]

The ideal hypnotic drug should allow the patient to fall asleep quickly, should maintain sleep of sufficient quality and duration so that the patient awakes refreshed without a drug hangover.[10] The contemporary system of medicine is lacking in fulfilling these criteria. Hence, it becomes imperative to search out treatment that is safe and effective, without any adverse effects or withdrawal phenomena, from natural systems of medicine.

Reflexology is a systematic practice in which applying some pressure to particular points on the feet and hands give impacts on the health of related parts of the body. Each point of the pressure acts as the sensors on the feet and hands and links with different parts of body specifically. These sensors will be stimulated by applying the reflexology technique in order to improve the blood and energy circulation which gives sense of relaxation.[11] Reflexology generally is used to solve problems such as stress, anxiety, depression, fatigue and insomnia etc in individuals.[12]

Paadabhyanga is one of the procedures among Bahirparimarjana Chikitsa. According to Brihattrayees,  Paadabhyanga brings good sleep, it is pleasing to body and eyes, removes fatigue and reduces Vata Dosha.[13,14,15] According to Acharya Yogaratnakara by massaging the feet it brings strength, induces sleep, beneficial to eyes and reduces tiredness and stiffness of the body.[16]

Considering the above factors, an attempt has been made to clinically evaluate  and compare the efficacy of  Foot reflexology and Paadabhyanga  in  Anidra.

 
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