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CTRI Number  CTRI/2026/03/105734 [Registered on: 09/03/2026] Trial Registered Prospectively
Last Modified On: 18/02/2026
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Study of ayurvedic medicine on disturbed sleep in diabetic patients. 
Scientific Title of Study   Prospective Controlled phase 2 clinical study to evaluate effect of sleep on glycemic control in type 2 diabetic subject W.S.R. to Dehaprakruti. 
Trial Acronym  Nil 
Secondary IDs if Any  
Secondary ID  Identifier 
SL/DM/PR/01/2024  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Madhavi Vaibhav Gaikwad 
Designation  PhD Scholar 
Affiliation  Matoshri Ayurved College Eklahre nashik 
Address  Ayurved Seva Sangh Ayurved Mahavidyalay, Nashik Ganeshwadi, Panchavati
Matoshree Atyrved College Eklahre Nashik
Nashik
MAHARASHTRA
422003
India 
Phone  9881182449  
Fax    
Email  gaikwad50madhavi@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Laxmikant G Joshi 
Designation  HOD Kriya sharir Ayurved Mahavidyalaya Nashik 
Affiliation  Ayurved Mahavidyalaya Nashik 
Address  Ayurved Seva Sangh Ayurved Mahavidyalay, Nashik Ganeshwadi, Panchavati

Nashik
MAHARASHTRA
422003
India 
Phone  8805548973  
Fax    
Email  lgjoshi06@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Laxmikant G Joshi 
Designation  HOD Kriya sharir Ayurved Mahavidyalaya Nashik 
Affiliation  Ayurved Mahavidyalaya Nashik 
Address  Ayurved Seva Sangh Ayurved Mahavidyalay, Nashik Ganeshwadi, Panchavati

Nashik
MAHARASHTRA
422003
India 
Phone  8805548973  
Fax    
Email  lgjoshi06@gmail.com  
 
Source of Monetary or Material Support  
Ayurved Seva Sangh Ayurved Mahavidyalaya Ganeshwadi Panchavati Nashik 422003 
 
Primary Sponsor  
Name  Dr Madhavi Vaibhav Gaikwad 
Address  Flat no 201 Orange Dream Citi near metro mall agar takli Nashik 422006 Maharashtra 
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 Madhavi Gaikwad  Ayurved Seva Sangh Arogyashala Rugnalaya Nashik  OPD no 9 Sanshodhan Vibhag OPD
Nashik
MAHARASHTRA 
9890149949

madhavi39gaikwad@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee,Ayurved Mahavidyalaya,Ayurved Seva Sangha,Nashik  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:E119||Type 2 diabetes mellitus without complications. Ayurveda Condition: PRAMEHAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Comparator Arm (Non Ayurveda)-Vildagliptin and MetforminVildagliptin 50 mg in combination wit Metformin 500 mg twice daily after meals for 90 days
2Intervention ArmDrugClassical(1) Medicine Name: Jatamansi Ghana, Reference: Sharangdhar, Route: Oral, Dosage Form: Ayaskriti, Dose: 500(mg), Frequency: od, Bhaishajya Kal: Adhobhakta, Duration: 90 Days, anupAna/sahapAna: Yes(details: -Water), Additional Information: -Along with Standard Diabetic Treatment protocol
 
Inclusion Criteria  
Age From  40.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Male and female participants aged between 40 to 60 years31 with known case of
type 2 DM
HbA1c 6.5to 8.5
Participants with impaired sleep defined as a Pittsburgh sleep quality score 5
Participants having history of disturbed sleep More than 30 minutes to fall
asleep and subjective total sleep time of 6.5 hours per night for at least 3
nights per week and daytime complaints associated with disturbed sleep
Participants not receiving any specific treatment for sleep improvement at the time of enrolment
Habitual bedtime between 8.30 pm and midnight
Participants willing to participate and give informed consent 
 
ExclusionCriteria 
Details  Participants below 40 years and above 60 years
Participants with uncontrolled blood sugar level and Hba1c more than 8.5
Pregnant or breast feeding women of women or women with positive urinary pregnancy test at screening Patients with known endocrine metabolic hepatic renal cardiovascular gastrointestinal respiratory haematological or neurological illness
Patients with current psychiatric disorders that are judged by investigator as potentially causing or contributing to insomnia
Patients who have received following medications in the period shown in
parentheses: Triazolam (1 Day) Alprazolam(2 days) Chlordiazepoxide (2
days) Temezepam(2days) Estazolam (3 days) Lorazepam (3 days) Diazepam
(7 days)
Patients with substance dependence/abuse in the past one year or with alcohol abuse are ineligible 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
1. Reduction in HbA1c levels in type 2 DM subjects having insomnia from
baseline
2. Improvement in Insomnia severity Index scale in Type 2 DM subjects using
Jatamansi Ghana from baseline. 
90 days 
 
Secondary Outcome  
Outcome  TimePoints 
Reduction in signs and symptoms of Madhumehain Type 2 DM  90 days 
 
Target Sample Size   Total Sample Size="140"
Sample Size from India="140" 
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/ Phase 4 
Date of First Enrollment (India)   09/03/2026 
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 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  
Sleep is a state of reduced mental & physical activity in which consciousness is altered & certain sensory activity is inhibited During sleep there is marked decreasein muscle activity & interactions with the surrounding environment  Good sleepi mproves your brain performance mood & health The functions of sleep include ahealthy mental state bodily sustenance physical vigor virility knowledge and life One of the things that keeps a living body alive is sleep Diabetes is a condition of pandemic proportions with increasing prevalence. In 2010 diabetes is estimated to affect 285 million people aged between 20 & 79 years worldwide & it is expected to affect almost 439 million people by 2030 Among the factors considered responsible for this sharp increase in prevalence are population aging unhealthy diet overweight & obesity & a sedentary lifestyle There is evidence that sleep impairment should also be considered a type 2 DM risk factor1 because in addition to leading to some risk factors listed above it seems to be independently associated with diabetes Ayurveda describes sleep as a basic instinct of life  essential to all living beings We need it to rejuvenate & reenergize our body mind & spirit In Ayurveda sleep is one of the 3 pillars of good health known as nidra Charak Samhita mentions 6 types of sleep
Diabetes which is a metabolic condition is referred to as Madhumeha in ayurvedic textsThe condition is caused due to an imbalance of doshas There are 20 types of Prameha due to imbalance of Tridoshas Insomnia is also known as sleeplessness It is a sleep disorder where people have trouble sleeping. They may have difficulty either falling asleep or staying asleep as long as desired. Insomnia is typically followed by low energy daytime sleepiness irritability and a depressed mood  Insomnia may be short-term lasting for days or weeks or long-term lasting more than a month Insomnia can occur independently or as a result of secondary effects of other conditions Conditions  which cause insomnia include psychological stress chronic pain hyperthyroidism heartburn restless leg syndrome menopause certain medications and drugs suchas caffeine nicotine and alcohol According to Ayurveda studies have shown that Jatamansi helps in balancing tridoshas  calm down the nervous system thus helps in inducing sound sleep and improve quality of sleep in patients An aggravated Vata dosha makes nervous system sensitive which leads to insomnia Hence jatamansi as a drug will be used
 
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