| CTRI Number |
CTRI/2025/10/096486 [Registered on: 27/10/2025] Trial Registered Prospectively |
| Last Modified On: |
16/10/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A study where patient suffering from Nidranasha(Insomnia) will be given ayurvedic medicine for treating Nidranasha (Insomnia) |
|
Scientific Title of Study
|
Randomized, Open Labelled, Clinical Trial Of Mansyadi Kashay In The Management Of Nidranasha w.s.r. To Stress Induced Insomnia In Control With Ashwagandha Churna |
| 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 Abhilasha Chatragun Lagad |
| Designation |
Assistant Professor and Phd scholar Kayachikitsa Department |
| Affiliation |
Dr. D.Y.Patil college of Ayurved and Reasearch centre, Sant Tukaram Nagar, Pimpri,Pune |
| Address |
Kayachikitsa Department, Ground Floor, Room no. 5, Dr. D.Y.Patil college of Ayurved and Reasearch centre, Sant Tukaram Nagar, Pimpri,Pune
Kayachikitsa Department, Ground floor, Room no. 18, Government Ayurved College and Hospital, Vajirabad,Nanded- 431602
Nanded
MAHARASHTRA
411018
India |
| Phone |
9284017168 |
| Fax |
|
| Email |
lagadabhilasha@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vishwas Eknath Gogate |
| Designation |
Guide and Head of the Department Kayachikitsa |
| Affiliation |
Government Ayurved College, Nanded |
| Address |
Kayachikitsa Department, Ground floor, Room no. 18, Government Ayurved College and Hospital, Vajirabad,Nanded- 431602
Nanded
MAHARASHTRA
431602
India |
| Phone |
9518916517 |
| Fax |
|
| Email |
vgogate21@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Abhilasha Chatragun Lagad |
| Designation |
Assistant Professor and Phd scholar Kayachikitsa Department |
| Affiliation |
Dr. D.Y.Patil college of Ayurved and Reasearch centre, Sant Tukaram Nagar, Pimpri,Pune |
| Address |
Kayachikitsa Department, Ground Floor, Room no. 5, Dr. D.Y.Patil college of Ayurved and Reasearch centre, Sant Tukaram Nagar, Pimpri,Pune
Kayachikitsa Department, Ground floor, Room no. 18, Government Ayurved College and Hospital, Vajirabad,Nanded-431602
Nanded
MAHARASHTRA
411018
India |
| Phone |
9284017168 |
| Fax |
|
| Email |
lagadabhilasha@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr. D.Y.Patil college of Ayurved and Research centre, Pimpri, Pune 411018, Maharashtra |
| Government Ayurved College, Vajirabad, Nanded- 431602 |
|
|
Primary Sponsor
|
| Name |
Dr. Abhilasha Chatragun Lagad |
| Address |
Dr. D.Y.Patil college of Ayurved and Research centre, Sant Tukaram Nagar, Pimpri-Pune-411018, 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 Abhilasha Chatragun Lagad |
Dr. D.Y.Patil Ayurved Hospital |
Room no. 5, Kayachikitsa OPD and IPD (Medicine) under Kayachikitsa Department, Pimpri
Pune
MAHARASHTRA |
9284017168
lagadabhilasha@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Government Ayurved College Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:G470||Insomnia. Ayurveda Condition: NIDRANASAH/ASVAPNAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Mansyadi Kashay, Reference: Vaidya Yadavaji Thrikamaji Acharya, Siddha Yoga Sangraha, Sri Bydhyanatha Ayurveda Bhavana Limited- Nagpura, 8th edition 1984, 109-110, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 20(ml), Frequency: hs, Bhaishajya Kal: Sabhakta, Duration: 15 Days, anupAna/sahapAna: Yes(details: Koshnajala), Additional Information: Mansyadi Kwatha | | 2 | Comparator Arm | Drug | Other than Classical | | (1) Medicine Name: Ashwagandha churna, Reference: NA, Route: Oral, Dosage Form: Churna/ Powder, Dose: 5(g), Frequency: hs, Bhaishajya Kal: Sabhakta, Duration: 15 Days, anupAna/sahapAna: Yes(details: Mahishi dugdha), Additional Information: |
|
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
Stressful life causing insomnia.
patients with SEI score were selected.
Willing to participate in study and ready to sign an informed consent.
|
|
| ExclusionCriteria |
| Details |
Patient with other systemic disorders
Patient with alcohol dependency or drug dependency.
Patient under Hypnotic medication, drug abuse
Physiological conditions like pregnancy, lactation and puerperal stage. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Changes in clinical features of Anidra (Insomnia) will be recorded before and after the treatment based on Improvement in SEI scoring Index. |
Pittsburgh Sleep Quality Index Score and Insomnia Severity INDEX Score will be assessed in questionnaire form at screening visit, baseline visit 0th, 7th, 16th, 30th day. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| The comparison of before and after improvement in symptoms like Angamarda ( Bodyache), Shiroguarav ( Heaviness in Head), Jrimbha ( yawning), Jadya ( Heaviness in body), Bhrama( Giddiness), Apakti (Indigestion), Nidra ( Sleep) |
The comparison of before and after improvement in symptoms
will be assessed at screening visit, baseline visit 0th, 7th, 16th, 30th day.
|
|
|
Target Sample Size
|
Total Sample Size="120"
Sample Size from India="120"
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/ Phase 3 |
|
Date of First Enrollment (India)
|
18/11/2025 |
| 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="3"
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
|
Study of the effect of the Mansyadi kashay (Jatamansi 540gm, Ashwagandha 1260gm, Parasik yavani 460gm) in patients suffering from stress induced insomnia fulfilling the inclusion criteria and comparing with Ashwagandha churna with Mahishi dugha anupan administration on randomly selected 120 patients. Total 120 patients will be enrolled for the study each patient will be given medication for a period of 15 days. |