| CTRI Number |
CTRI/2026/02/103166 [Registered on: 06/02/2026] Trial Registered Prospectively |
| Last Modified On: |
05/02/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda
Behavioral |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Study to evaluate effect
Of oral administration of Jatamansi tablet with Counselling Therapy for Improving Sleeplessness and quality of sleep |
|
Scientific Title of Study
|
Double blind placebo control randomised clinical trial to evaluate add on effect
Of oral administration of Jatamansi tablet with cognitive behavioral therapy For insomnia (CBT-I) in the management of insomnia during perimenopause |
| 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 Savita Pawar |
| Designation |
PG Scholar |
| Affiliation |
Amrita school of ayurveda kerala india |
| Address |
Department of Prasutitantra and Streeroga, Amrita School of Ayurveda, P.O.Kollam 690525
Kerala . India
Kollam
KERALA
690525
India |
| Phone |
9272005821 |
| Fax |
|
| Email |
pawar.savi11@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Parvathy Unni Krishnan |
| Designation |
Associate professor |
| Affiliation |
Amrita school of ayurveda kerala india |
| Address |
Department of Prasutitantra and Streeroga, Amrita School of Ayurveda, P.O.Kollam 690525
Kerala. India
Kollam
KERALA
690525
India |
| Phone |
9497882775 |
| Fax |
|
| Email |
parvathyunnikrishnannair@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Parvathy Unni Krishnan |
| Designation |
Associate professor |
| Affiliation |
Amrita school of ayurveda kerala india |
| Address |
Department of Prasutitantra and Streeroga, Amrita School of Ayurveda, P.O.Kollam 690525
Kerala. India
Kollam
KERALA
690525
India |
| Phone |
9497882775 |
| Fax |
|
| Email |
parvathyunnikrishnannair@gmail.com |
|
|
Source of Monetary or Material Support
|
| Amrita School of Ayurveda, Amrita Vishwa Vidyapeetham, Amritapuri, Clappana P.O.Kerala, India 690525 |
|
|
Primary Sponsor
|
| Name |
Dr Savita Pawar |
| Address |
Department of Prasutitantra and Streeroga, Amrita School of Ayurveda, P.O.Kollam 690525
Kerala . India |
| 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 Savita Pawar |
Amrita School of Ayurveda Hospital |
Department of Prasutitantra and Streeroga (OPD NO. 5 )Amrita School of Ayurveda,PO Clappana Kollam, Kerala
Kollam
KERALA |
9272005821
pawar.savi11@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Amrita School of Ayurveda |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:F40-F48||Anxiety, dissociative, stress-related, somatoform and other nonpsychotic mental disorders. Ayurveda Condition: NIDRANASAH/ASVAPNAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Jatamansi, Reference: Bhavprakasha Nighantu, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 650(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 30 Days, anupAna/sahapAna: No, Additional Information: -nil | | 2 | Comparator Arm (Non Ayurveda) | | - | Cognitive Behavioral Therapy for Insomnia | CBT-I Sessions will be given for 1 month.Total 8 sessions will be conducted. Session length vary between 30-45min.
|
|
|
|
Inclusion Criteria
|
| Age From |
45.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Female |
| Details |
Women aged 45 to 55 years.
Insomnia Severity Index. (ISI) (score in between 8-21 indicating sub threshold insomnia to moderate insomnia)
Duration of insomnia greater than 1 month, greater than 3 nights/week.
Able to understand and comply with CBT instructions.
Give written informed consent.
Mild to moderate case of insomnia. |
|
| ExclusionCriteria |
| Details |
Known cases of Hypertension, Thyroid disorders, and Diabetes Mellitus.
PHQ-9 Depression scale Score greater than 5
Under medication for any psychological or psychiatric disorders, substance use.
Habitual caffeine intake exceeding 400mg/day(equivalent to approximately 4 cups (240 ml each) of brewed coffee or any comparable caffeine sources
Current insomnia treatment.
Known case of pelvic pathology.
Hormonal therapy.
Severe case of insomnia.
No access to mobile phones and internet.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Insomnia severity reduction: A clinically significant improvement defined as a greater than or equal to 7-point reduction in ISI score from baseline to 4 weeks.
Sleep quality improvement: A greater than or equal to 3-point reduction in PSQI score from baseline to 4 weeks considered clinically meaningful.
|
4months
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Insomnia severity reduction: A clinically significant improvement defined as a greater than or equal to 7-point reduction in ISI score from baseline to two weeks.
Quality of life enhancement: A greater than or equal to 10% increase in Q-LES-Q-SF score from baseline to 4 weeks indicating improved satisfaction and enjoyment.
|
4 months |
|
|
Target Sample Size
|
Total Sample Size="64"
Sample Size from India="64"
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 2 |
|
Date of First Enrollment (India)
|
16/02/2026 |
| 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="0"
Months="11"
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
|
This is double blind placebo control randomized clinical trial to evaluate add on effect of oral administration of 650 mg (one tablet twice daily)of Jatamansi with Cognitive Behavioural Therapy for Insomnia (CBT-I) for one month compared to CBT-I added with placebo (corn starch) in women of 45 to 55 years of age in the management of Insomnia during Perimenopause.
Primary Objective- To determine a minimum 7-point reduction in the Insomnia Severity Index (ISI) score after 4 weeks of intervention with Cognitive Behavioural Therapy- Insomnia added with the Jatamansi tablet compared to Cognitive Behavioural Therapy- Insomina added with placebo(corn starch). To determine a minimum 3-point reduction in the Pittsburgh Sleep Quality Index (PSQI) score after 4 weeks of intervention with Cognitive Behavioural Therapy- Insomnia added with Jatamansi tablet, compared to Cognitive Behavioural Therapy- Insomnia added with placebo(corn starch).
Secondary Objective- To determine the early onset of therapeutic response within the first two weeks of intervention using the Insomnia Severity Index (ISI), with a focus on changes in the severity of insomnia. To determine the Improvement in Quality of Life through an increase in scores of the Quality of Life Enjoyment and Satisfaction Questionnaire Short Form (Q-LES-Q SF).
|