| 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
|
|
|
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
|
|
|
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
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm (Non Ayurveda) | | - | Vildagliptin and Metformin | Vildagliptin 50 mg in combination wit Metformin 500 mg twice daily after meals for 90 days | | 2 | Intervention Arm | Drug | Classical | | (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 |