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CTRI Number  CTRI/2024/02/063116 [Registered on: 23/02/2024] Trial Registered Prospectively
Last Modified On: 12/02/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Homeopathy
Behavioral 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   Sleep hygiene and Homoeopathy 
Scientific Title of Study   PHASE I: "To assess Sleep Hygiene among students aged between 12 to 19 years in South Andaman district of Andaman and Nicobar Islands: A Cross-sectional Study" PHASE II: " To evaluate the role of individualiuzed homoeopathic medicines in Sleep hygiene in the adolescent age group: A double arm, single blind, randomized, placebo-controlled study" 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Santi Adhikary 
Designation  Research Officer (Homoeopathy) 
Affiliation  Central Council for Research in Homoeopathy, New Delhi 
Address  Clinical Research Unit for Homoeopathy, Port Blair M.B.31, M.G.Road, Middle Point,Port Blair
61-65, Institutional Area, New Delhi 110058
Andamans
ANDAMAN & NICOBAR ISLANDS
744101
India 
Phone  919836262103  
Fax    
Email  santi.adhikary2012@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Santi Adhikary 
Designation  Research Officer (Homoeopathy) 
Affiliation  Central Council for Research in Homoeopathy, New Delhi 
Address  Clinical Research Unit for Homoeopathy, Port Blair M.B.31, M.G.Road, Middle Point,Port Blair
61-65, Institutional Area, New Delhi 110058
Andamans
ANDAMAN & NICOBAR ISLANDS
744101
India 
Phone  919836262103  
Fax    
Email  santi.adhikary2012@gmail.com  
 
Details of Contact Person
Public Query  
Name  Harleen Kaur 
Designation  Research Officer (Homoeopathy) 
Affiliation  Central Council for Research in Homoaopathy 
Address  Central Council for Research in Homoaopathy Division- Clinical Research 61-65, Institutional Area, New Delhi,India

West
DELHI
110058
India 
Phone  919818709729  
Fax    
Email  dr.harleenkaur@gmail.com  
 
Source of Monetary or Material Support  
Central Council for Research in Homoeopathy, an autonomous body under Ministry of AYUSH 
 
Primary Sponsor  
Name  Central Council for Research in Homoeopathy 
Address  61-65, Institutional Area, New Delhi-110058 
Type of Sponsor  Research institution 
 
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 Santi Adhikary  Clinical Research Unit for Homoeopathy, Port Blair  Dept of Clinical research,Room no.01, Division: Clinical Research M.B.31,M.G. Road, Middle Point,Port Blair
Andamans
ANDAMAN & NICOBAR ISLANDS 		 919836262103

santi.adhikary2012@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committe- Clinical Research Unit(Homoeopathy), Port Blair  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: Z729||Problem related to lifestyle, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Homoeopathic Medicines  Homoeopathic drugs as detailed in the Homoeopathic Pharmacopoeia (India) will be used in the study based on symptom similarity (Homoeopathic principle). The drugs identified for the trial shall be procured from a GMP compliant pharmaceutical firm. The drugs must be prescribed on the basis of symptom totality and justification of prescription must be recorded in the case taking Performa. Only single medicines would be permitted to be used at a time, orally. At the start of treatment, the selected medicine would be prescribed in 6C potency. During the period of the study, the potency would be raised sequentially (like 30, 200, 1M) as per the need of the case, in pursuance with the homoeopathic principles. Follow up of the case will be done at the interval of every thirty (30) days (or earlier, if required) for a period six (6) months. 
Comparator Agent  Placebo  Non medicated sugar globules orally 
 
Inclusion Criteria  
Age From  12.00 Year(s)
Age To  19.00 Year(s)
Gender  Both 
Details  (Phase I)
1. Individuals between 12-19 years of age, of any gender and studying in schools/ colleges around the Port Blair unit, willing to participate in the survey.

(Phase II)
1. Individuals between 12-19 years of any gender having difficulty in falling asleep and/or remaining asleep, and scoring below 4.9 on Adolescent Sleep Hygiene Scale (ASHS) from the phase I study and other patients visiting to CRU, Port Blair OPD; willing to participate in the study.
 
 
ExclusionCriteria 
Details  1. Any pre-existing, known psychiatric illness.
2. ASHS score equal or above 4.9.
3. Age not within the range of 12-19 years
4. Other systemic, life-threatening illnesses like cancer, malignant hypertension, renal, hepatic or cardiac failure etc.
5. Treatment with immune-modulating oral medications in past one month.
6. Pregnant or Lactating women.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
1.Prevalence of sleep hygiene issues in the target population as evaluated on ASHS scale (Phase I).
2.Comparing the changes in ASHS score during 6-month treatment (Phase II) between the treatment and controlled group.
 		 Comparing the changes in ASHS score during 6-month treatment (Phase II) between the treatment and controlled group.
 
 
Secondary Outcome  
Outcome  TimePoints 
Not applicable  Not applicable 
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
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)   01/03/2024 
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="0"
Months="9"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
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   Title: Role of individualized homoeopathic medicines in sleep hygiene in the adolescent age group

Short title:   Sleep hygiene and Homoeopathy

Study design:Survey, followed by a randomized placebo-controlled study

PHASE I: To assess Sleep Hygiene among students aged between 12 to 19 years in South Andaman district of Andaman and Nicobar Islands: A Cross-sectional Study.

PHASE II: To Evaluate the role of individualized homoeopathic medicines in sleep hygiene in the adolescent age group: A double arm, single blind, randomized, placebo -controlled study.

Study duration:  1 year;

Cross-sectional survey; Phase I: 3 months

Randomized, placebo-controlled study, Phase II: 6 months

Analysis and manuscript writing: 3 months

Background & Rationale           Sleep patterns in adolescents need adequate attention because of the potential impact on academic performance, social behavior, and cardio-metabolic system1. Psychosocial factors like academic and social demands, physiological concomitants of puberty, and environmental factors like reduced parental influence at bedtime, extracurricular activities, like watching television, playing videogames on mobile or computer, engaging in social media and other internet-based applications cause a reduced sleep time2. A systematic review reported that bedtime use and access to hand-held media devices were significantly associated with inadequate sleep quality, poor sleep quality, and excessive daytime sleepiness.3 Gupta R et al., did a study of sleep patterns amongst urban Indian school going adolescents from classes ninth to twelfth grade. They reported that adolescents of higher grades suffered from increasing sleep debt and lesser sleep time with increasing classes 4. A similar study was done by Selvakumar L. et al. on sleep hygiene in adolescents and factors influencing sleep pattern. They concluded that school based and family based intervention is necessary to maintain proper sleep hygiene 5.

The ASHS is a 33-item self-report questionnaire that assesses sleep-facilitating and sleep-inhibiting practices in adolescents along nine different domains: physiological, cognitive, emotional, sleep environment, daytime sleep, substances, bedtime routine, sleep stability, and bed/bedroom sharing5. Score less than 3.8 is to be considered as poor sleep hygiene whereas score greater than 4.9 symbolizes a good sleep hygiene29.

Even though there are no studies reported on the role of homoeopathic medicines on sleep hygiene, there are a few evaluating their role in insomnia, a related condition. A systematic review of these studies, however, warrant for better quality studies with greater power to ascertain the role. This study, thus, would be, a much-required step in this direction.

Objectives       

1.         Primary

a.         To assess prevalence of sleep disturbances in the adolescent age group between 12 to 19 years

b.         To evaluate the efficacy of Individualized Homoeopathic Medicines in improving sleep hygiene in the adolescent age group between 12 to 19 years of residing in South Andaman district, A&N islands.

 

2.         Secondary

a.         To identify the factors disrupting the sleep cycle

b.         Validation of indications of homoeopathic medicines used in the study

 

Diagnosis and main inclusion criteria    

Inclusion Criteria

(Phase I)

• Individuals between 12-19 years of age, of any gender and studying in schools/ colleges around the Port Blair unit, willing to participate in the survey.

 

(Phase II)

• Individuals between 12-19 years of any gender having difficulty in falling asleep and/or remaining asleep, and scoring below 4.9 on Adolescent Sleep Hygiene Scale (ASHS) from the phase I study and other patients visiting to CRU, Port Blair OPD; willing to participate in the study.

Exclusion criteria         

• Any pre-existing, known psychiatric, systemic, life-threatening illnesses like cancer, malignant hypertension, renal, hepatic or cardiac failure etc.illness.

• ASHS score equal or above 4.9.

•  Treatment with immune-modulating oral medications in past one month.

•  Pregnant or Lactating women


Sample size:

Phase I: 369

Phase II: 86

Study Product, Dose, Route, Regimen: Individualized homoeopathic medicine based on Homoeopathic principles in appropriate dose, orally.

Follow up: Phase 2: Every 15 days for first 2 months, and then once a month for remaining four months.

Outcomes       

Primary Outcomes:

1. Prevalence of sleep hygiene issues in the target population as evaluated on ASHS scale (Phase I).

2.Comparing the changes in ASHS score during 6-month treatment (Phase II) between the treatment and controlled group.

Statistical Methodology: Descriptive statistics (frequency distribution, mean and standard deviation) and inferential statistics like chi-squared tests and paired t-test will be used for analysis. Pearson correlation will be used to correlate variables.

Funding by: Central Council for Research in Homoeopathy, Ministry of AYUSH, Govt. of India.

Study Team

1. Dr. Santi Adhikary, RO(H)/S-1, CRU (H) Port Blair: PI

2. Dr. Harleen Kaur, RO(H)/S-2, CCRH, New Delhi: Co-PI

3. Dr. Tania Chatterjee, SRF(H), CCRH, New Delhi

4. Dr. Nargis Anwar, SRF(H), CRU (H) Port Blair

 
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