| CTRI Number |
CTRI/2026/02/103581 [Registered on: 10/02/2026] Trial Registered Prospectively |
| Last Modified On: |
09/02/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Use Of Kakajanghadi Kwatha In Nidranasha (Primary Insomnia) |
|
Scientific Title of Study
|
Randomized Controlled Clinical Trial Of Kakajanghadi Kwatha In Nidranasha With Special Reference To Primary 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 Trupti Balasaheb Bhosale |
| Designation |
PG Scholar |
| Affiliation |
Hon Shri Annasaheb Dange Ayurved Medical College Post Graduate And Research Center Ashta |
| Address |
Department Of Kayachikitsa Hon Shri Annasaheb Dange Ayurved Medical College Post Graduate And Research Center And Dhanwantari Hospital Ashta
Sangli MAHARASHTRA 416301 India |
| Phone |
9890468925 |
| Fax |
|
| Email |
truptibhosale8925@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Varsha Sadashiv Khot |
| Designation |
Associate Professor |
| Affiliation |
Hon Shri Annasaheb Dange Ayurved Medical College Post Graduate And Research Center Ashta |
| Address |
Department Of Kayachikitsa Hon Shri Annasaheb Dange Ayurved Medical College Post Graduate And Research Center And Dhanwantari Hospital Ashta
Sangli MAHARASHTRA 416301 India |
| Phone |
9423565886 |
| Fax |
|
| Email |
drvarshaskhot@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Varsha Sadashiv Khot |
| Designation |
Associate Professor |
| Affiliation |
Hon Shri Annasaheb Dange Ayurved Medical College Post Graduate And Research Center Ashta |
| Address |
Department Of Kayachikitsa Hon Shri Annasaheb Dange Ayurved Medical College Post Graduate And Research Center And Dhanwantari Hospital Ashta
Sangli MAHARASHTRA 416301 India |
| Phone |
9423565886 |
| Fax |
|
| Email |
drvarshaskhot@gmail.com |
|
|
Source of Monetary or Material Support
|
| Hon Shri Annasaheb Dange Ayurved Medical College Post Graduate And Research Center Ashta Taluka Walwa District Sangli Maharastra 416301 India |
|
|
Primary Sponsor
|
| Name |
Dr Trupti Balasaheb Bhosale |
| Address |
OPD No1 Kayachikitsa OPD Hon Shri Annasaheb Dange Ayurved Medical College Post Graduate And Research Center and Dhanwantari Hospital Ashta Taluka Walwa District Sangli Maharastra 416301 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 Trupti Balasaheb Bhosale |
Hon Shri Annasaheb Dange Ayurved Medical College Post Graduate And Research Center Ashta |
Department Of
Kayachikitsa
OPD/IPD
Sangli
MAHARASHTRA Sangli MAHARASHTRA |
9890468925
truptibhosale8925@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Of Hon Shri Annasaheb Dange Ayurved Medical College Post Graduate And Research Center Ashta Sangli |
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: Kakajanghadi Kwatha, Reference: Harit Samhita Tru.15/ 6, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 24(ml), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 30 Days, anupAna/sahapAna: No, Additional Information: - | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Mamsyadi Kwatha, Reference: Siddha Yoga Sara Sangraha Bhrama Anidra Unmadodhikara, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 24(ml), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 30 Days, anupAna/sahapAna: No, Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients having insomnia according to Insomnia severity index Scale greater than or equal 8 primary insomnia
2.Age group 18 to 60 years
3.Patients irrespective of gender socioeconomic conditions
|
|
| ExclusionCriteria |
| Details |
1. Secondary Insomnia due to Medical condition Psychiatric disorder, Medications, Substance abuse or Withdrawal.
2. Pregnant & Lactating women |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Kakajangahdi Kwatha Is Effective In Management Of Nidranasha |
0 day,10th day,20th day,30th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Decrease Symptoms after 30 days |
30 Days |
|
|
Target Sample Size
|
Total Sample Size="68" Sample Size from India="68"
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)
|
14/03/2026 |
| 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="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
|
Mental health is defined by the World Health Organization as a state of wellbeing in which an individual realizes their abilities, manages daily stress, works productively, and contributes to society. Ayurveda emphasizes the importance of health through the concept of Trayopstambha—Brahmacharya (celibacy), Nidra (sleep), and Ahara (diet)—which are considered the supporting pillars of life. Among these, Nidra plays a crucial role in maintaining both physical and mental health. Acharya Charaka described sleep as a state that occurs when the sense and motor organs become inactive and the mind and soul experience fatigue. Nidranasha (insomnia) is described in Ayurvedic classics as a Vataja disorder, and sleep disturbances have also been explained by Acharya Sushruta. In the modern era, insomnia has become increasingly common and is characterized by difficulty in initiating or maintaining sleep, leading to impaired daytime functioning. Primary insomnia occurs without any identifiable medical, psychological, or environmental cause. Modern medical treatments mainly rely on sedatives and hypnotics, which provide temporary relief but are associated with side effects such as dependency, withdrawal symptoms, and cognitive impairment. These limitations have increased interest in safer and holistic treatment approaches. Ayurveda offers various treatment modalities for Nidranasha. Kakajanghadi Kwatha, described in Harita Samhita, is believed to calm the nervous system, balance aggravated doshas, and promote natural sleep without adverse effects. A clinical study was conducted with 68 subjects divided into two groups: a trial group receiving Kakajanghadi Kwatha and a control group receiving Mamsyadi Kwatha. Both groups were administered 24 ml of the respective decoction orally, twice daily for 30 days, with follow-ups on the 10th, 20th, and 30th day. |