| CTRI Number |
CTRI/2025/03/082742 [Registered on: 19/03/2025] Trial Registered Prospectively |
| Last Modified On: |
29/01/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
to check the efficacy of kantkaryadi kwath
And jatamansyadi kwath churna in patient of anidra(insomnia)
|
|
Scientific Title of Study
|
A randomised controlled
Clinical study to evaluate the efficacy of Kantkaryadi Kwath
And Jatamansyadi Kwath Churna in the management of Anidra
With special reference to Insomnia
|
| 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 Asha |
| Designation |
P.G. Scholar |
| Affiliation |
INSTITUTE FOR AYURVED STUDIES AND RESEARCH |
| Address |
Room no 56, PG Department of Kayachikitsa
Institute for Ayurved Studies and Research Umri road sector 8 KURUKSHETRA
Kurukshetra
HARYANA
136118
India |
| Phone |
8168579446 |
| Fax |
|
| Email |
drashasahu96@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Neelam Kumari |
| Designation |
Professor, Department of Kayachikitsa |
| Affiliation |
INSTITUTE FOR AYURVED STUDIES AND RESEARCH |
| Address |
Room no 56, PG Department of Kayachikitsa
Room no 56, PG Department of Kayachikitsa Institute for Ayurved Studies and Research Umri road sector 8 KURUKSHETRA
Kurukshetra
HARYANA
136118
India |
| Phone |
9671368058 |
| Fax |
|
| Email |
mehranilam@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Neelam Kumari |
| Designation |
Professor, Department of Kayachikitsa |
| Affiliation |
INSTITUTE FOR AYURVED STUDIES AND RESEARCH |
| Address |
Room no 56, PG Department of Kayachikitsa
Room no 56, PG Department of Kayachikitsa Institute for Ayurved Studies and Research Umri road sector 8 KURUKSHETRA
HARYANA
136118
India |
| Phone |
9671368058 |
| Fax |
|
| Email |
mehranilam@gmail.com |
|
|
Source of Monetary or Material Support
|
| Institute For Ayurved Studies And Research, Umri road, sector 8, Kurukshetra pin 136118, Haryana, India |
|
|
Primary Sponsor
|
| Name |
Institute For Ayurved Studies And Research Umri road sector Kurukshetra |
| Address |
sector 8, Umri road, Kurukshetra pin 136118, Haryana, India |
| Type of Sponsor |
Government medical college |
|
|
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 Asha |
Institute for Ayurved Studies and Research |
Room no 56, PG Department of Kayachikitsa Institute for Ayurved Studies and Research Umri road sector 8 KURUKSHETRA
Kurukshetra
HARYANA |
8168579446
drashasahu96@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Shri Krishna Ayush University |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:F01-F99||Mental, Behavioral and Neurodevelopmental 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: Kantkaryadi kwath, Reference: Harit Samhita Chikitsa Sthan chapter 15 Verse 5, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 50(ml), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 28 Days, anupAna/sahapAna: No, Additional Information: - | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: jatamansyadi kwath churna, Reference: Ayurvedic Formulary of India Part III, Formulation of churna 4.10, Route: Oral, Dosage Form: Churna/ Powder, Dose: 6(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 28 Days, anupAna/sahapAna: Yes(details: -honey), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1 Confirmed diagnosis of Anidra (Primary Insomnia)
2 Patient who meets the criteria for mild to moderate in assessment criteria.
3 Individuals of any gender, regardless of their socio-economic condition.
4 Subjects who are ready to take part in the study with their consent. |
|
| ExclusionCriteria |
| Details |
1 Insomnia also known as Anidra caused by several disorders such as Madatyaya (alcoholism), Abhigyata(injury), and other systemic ailments.
2 Psychiatric patients receiving medical treatment. Drug induced insomnia
3 Patients who are already on treatment for insomnia.
4 Pregnant and lactating women.
5 Chronic debilitating diseases. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
1 The primary outcome of this study is to evaluate the effectiveness of Kantkaryadi Kwath in comparision to Jatamansyadi Kwath Churna in the treatment of insomnia. This will be assessed by measuring changes in the Athens Insomnia Scale (AIS) and Pittsburgh Sleep Quality Index (PSQI) scores, with the expectation of significant improvements in sleep quality and reduction in insomnia symptoms.
2 The proportion of patients exhibiting significant improvement in their scores on the
Athens Insomnia Scale (AIS) and the Pittsburgh Sleep Quality Index (PSQI) |
28 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Include improvements in emotional well-being, reduction in negative emotions, physical and mental growth, reduction in wasted
time and resources, increased strength, reduction in weakness, enhanced cognitive
performance, reduction in ignorance, and overall improvement in quality of life. |
7th 14th 21th 28th days |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
20/05/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
20/05/2025 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
The concept of Nidra, as described in Traya Upstamabha by Aacharya Charak, underscores the critical role of maintaining harmony to sustain individual health. Sleep is accorded equal significance as "Aahara" (diet) and "Bramhacharya" (celibacy). These three actions must be engaged in thoughtfully to preserve optimal health. Maharishi Charak elucidates that various aspects of human existence including happiness, misery, growth, waste, strength, weakness, virility, sterility, knowledge, ignorance, life, and death are all influenced by the quality of sleep. In the current era, characterized by intense competition and a constant chase for success, the quality and patterns of sleep are frequently disturbed. Insomnia, defined as a lack of sufficient and satisfactory sleep, is addressed in Ayurvedic texts under terms such as Nidranash, Asavpna, and Anidra. According to Charak, Nidranash is categorized under ’vataj nanatamaj vikar,’ whereas Sushrut attributes it to the aggregation of vata and pitta doshas. Numerous studies demonstrate that sedatives significantly enhance sleep quality. Their long term effectiveness is minimal, with various side effects and a high risk of dependency. Consequently, there is an imperative need to manage insomnia effectively using natural methods. Numerous herbal formulations and procedures outlined in Ayurvedic texts present viable approaches for the management of Anidra. |