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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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:G470||Insomnia. Ayurveda Condition: NIDRANASAH/ASVAPNAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmDrugClassical(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: -
2Comparator ArmDrugClassical(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. 

 
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