| 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] |
|
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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 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 |
|
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Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SRI SRI INSTITUTIONAL ETHICAL COMMITTEE |
Approved |
|
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Regulatory Clearance Status from DCGI
|
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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
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | 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.)
| | 2 | Comparator Arm | Procedure | - | 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 |
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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.
|
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| ExclusionCriteria |
|
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Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Open Label |
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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 .
|
|
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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 |
|
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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
|
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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. |