FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2023/12/060903 [Registered on: 28/12/2023] Trial Registered Prospectively
Last Modified On: 20/12/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Efficacy,of Jatamamsitailam nasya,gudapippalimoola avalehya and Sirodhara with Jatamamsi taila in primary insomnia 
Scientific Title of Study   Clinical Evaluation of efficacy of Jatamamsi Tailam Nasya over Gudapippalimoola avalehya (Oral) and Sirodhara with Jatamamsi Taila in Anidra wsr 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  Soma Alekya 
Designation  MD Kayachikitsa scholar 
Affiliation  DR BRKR GOVT.AYURVEDIC MEDICAL COLLEGE AND HOSPITAL ERRAGADDA HYDERABAD TELANGANA 
Address  Dr BRKR govt ayurvedic medical college and hospital,erragadda hyderabad telangana 500038
Dr BRKR govt ayurvedic medical college and hospital,erragadda hyderabad telangana 500038
Hyderabad
TELANGANA
500038
India 
Phone  7893231165  
Fax    
Email  alekhya1.soma@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr.P.Srikanth Babu 
Designation  MD (AYU) Professor and HOD department of kayachikitsa 
Affiliation  Dr BRKR govt ayurvedic medical college and hospital,erragadda hyderabad telangana 500038 
Address  Dr BRKR govt ayurvedic medical college and hospital,erragadda hyderabad telangana 500038
Dr BRKR govt ayurvedic medical college and hospital,erragadda hyderabad telangana 500038
Hyderabad
TELANGANA
500038
India 
Phone  09849463878  
Fax    
Email  drperugu@gmail.com  
 
Details of Contact Person
Public Query  
Name  Soma Alekya 
Designation  MD Kayachikitsa scholar 
Affiliation  Dr BRKR govt ayurvedic medical college and hospital,erragadda hyderabad telangana 500038 
Address  Dr BRKR govt ayurvedic medical college and hospital,erragadda hyderabad telangana 500038
Dr BRKR govt ayurvedic medical college and hospital,erragadda hyderabad telangana 500038
Hyderabad
TELANGANA
500038
India 
Phone  7893231165  
Fax    
Email  drperugu@gmail.com  
 
Source of Monetary or Material Support  
Dr BRKR govt ayurvedic medical college and hospital,erragadda hyderabad telangana 500038 
 
Primary Sponsor  
Name  Soma Alekya 
Address  Dr BRKR govt ayurvedic medical college and hospital,erragadda hyderabad telangana 500038 
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 
Soma Alekya  Room no:1 Department of kayachikitsa Govt ayurvedic hospital,erragadda,hyderabad,Telangana 500038  Govt Ayurvedic Hospital erragadda,hyderabad Telangana 500038
Hyderabad
TELANGANA 		 07893231165

alekhya1.soma@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
THE INSTITUTIONAL ETHICAL COMMITTEE OF DR BRKRGOVERNMENT AYURVEDIC COLLEGE,HYDERABAD  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:G00-G99||Diseases of the nervous system. Ayurveda Condition: MANOVAHASROTOVIKARAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Comparator ArmProcedure-SiraHsekaH, शिरःसेकः (Procedure Reference: Astanga hridaya, Procedure details: 450 to 500 ml of jatamamsi taila is poured over forehead for about 40 minutes with a help of sirodharapatra at a height of 2 feet above mid point of center of patients forehead for 7 days with a gap of 7 days.)
(1) Medicine Name: Jatamamsi taila , Reference: priyanighantu, Route: Topical, Dosage Form: Taila, Dose: 500(ml), Frequency: od, Duration: 28 Days
2Comparator ArmDrugClassical(1) Medicine Name: Gudapippalimoola, Reference: Vangasena 2nd chapter,Jwara rogadhikara,579/580, Route: Oral, Dosage Form: Avleha/Leha/Paka/Raskriya, Dose: 8(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 28 Days, anupAna/sahapAna: Yes(details: -ksheera), Additional Information: -
3Comparator ArmProcedure-nasyam/ nastam, नस्यम्/ नस्तम् (Procedure Reference: Charaka samhitha,Astangahridaya, Procedure details: 2 Cycles of nasya which will consist jatamamsi taila pratimarsha nasya(2drops) instillation in each nostril one time per day for 7 days with a gap of 7 days.)
(1) Medicine Name: Jatamamsi, Reference: Priyanighantu,36, Route: Nasal, Dosage Form: Taila, Dose: 2(drops), Frequency: od, Duration: 28 Days
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Patients who present with clinical features of sleeplessness.
Patients who are indicated for Nasya and Sirodhara karma.

Patients willing to give written consent.
 
 
ExclusionCriteria 
Details  1) Patients of age group below 20 years and above 60 years of either gender.

2) Patients contraindicated for Sirodhara karma and Nasya karma

3) Patient using known medication for anxiety and sedative or any psychiatric medicine

4) Patients suffering with secondary insomnia

5) Associated with major diseases like malignancy, epilepsy, Uncontrolled Hypertension and
Diabetes

6) Pregnant ladies and lactating mothers.
 
 
Method of Generating Random Sequence   Random Number Table 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
1.to contribute health by inducing a better sleep.
2.simple and effective solution for insomnia based on ayurvedic pramana
 		 28 days 
 
Secondary Outcome  
Outcome  TimePoints 
1.to to regulate healthy sleep pattern.  28 days 
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
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 3 
Date of First Enrollment (India)   05/01/2024 
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 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   Altered life style severely alters the sleep patterns.,altered sleep patterns lead to many diseases effecting the idividuals capabilities. 
sleep as such a very big issue not only at individual level but also interfering into social isuue as community is grossly effected,My intention is to contribute health by inducing a better sleep cycle -which also inturn regulate the quality of life of individual. Hence I have preffered Jatamamsitaila Nasya and Dhara and gudapippalimula(oral) to find some simple and effective solutions for insomnia based on ayurvedic pramana.
 
Close