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CTRI Number  CTRI/2023/06/054584 [Registered on: 30/06/2023] Trial Registered Prospectively
Last Modified On: 19/09/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Single Arm Study 
Public Title of Study   An ayurvedic medicine with yoga in premenstual psychological issues 
Scientific Title of Study   Effect of Kalyānaka ghá¹›ta with the selected Yoga protocol in moderate to severe premenstrual dysphoric disorder – single group pretest - posttest trial  
Trial Acronym  nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Jancy K S 
Designation  P G Scholar 
Affiliation  Vaidyaratnam PS Varier Ayurveda college kottakkal 
Address  P G Scholar Manovigyan avum manasroga Department of Kaya chikitsa Vaidyaratnam PS Varier Ayurveda college kottakkal Malappuram KERALA 676501 India

Malappuram
KERALA
676501
India 
Phone  8547490836  
Fax    
Email  jancyksurendran@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  DrJithesh M  
Designation  Professor and HOD  
Affiliation  Vaidyaratnam PS Varier Ayurveda college kottakkal 
Address  Department of Kaya chikitsa Vaidyaratnam PS Varier Ayurveda college kottakkal Malappuram KERALA 676501 India

Malappuram
KERALA
676501
India 
Phone  9447882885  
Fax    
Email  drjitheshm@gmail.com  
 
Details of Contact Person
Public Query  
Name  DrJithesh M  
Designation  Professor and HOD  
Affiliation  Vaidyaratnam PS Varier Ayurveda college kottakkal 
Address  Department of Kaya chikitsa Vaidyaratnam PS Varier Ayurveda college kottakkal Malappuram KERALA 676501 India

Malappuram
KERALA
676501
India 
Phone  9447882885  
Fax    
Email  drjitheshm@gmail.com  
 
Source of Monetary or Material Support  
Department of Kayachikitsa VPSV Ayurveda college kottakkal  
 
Primary Sponsor  
Name  Jancy K S 
Address  PG Scholar Manovigyan Avum Manasaroga Department of Kayachikitsa VPSV Ayurveda college kottakkal  
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 
Jancy K S  Vaidyaratnam PS Varier Ayurveda Hospital kottakkal  manasanthi op,room number 205 and prasuthi op room number 202 p o Edarikode malappuram kerala pin 676501
Malappuram
KERALA 		 08547490836

jancyksurendran@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional ethics committee Vaidyaratnm PS Varier Ayurveda college  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:F328||Other depressive episodes. Ayurveda Condition: ARutava saMbandha viShada,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmDrugClassical(1) Medicine Name: kalyanaka gritha, Reference: Ashtanga Hridaya, Route: Oral, Dosage Form: Ghrita, Dose: 10(ml), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 60 Days, anupAna/sahapAna: Yes(details: -warm water), Additional Information: yoga
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  40.00 Year(s)
Gender  Female 
Details  Subjects fulfilling the diagnostic criteria for premenstrual dysphoric disorder as per DSM 5.
•Moderate to severe PMDD by – Premenstrual symptom screening tool (PSST).
•Women in the age group of 18 – 40 yrs.
•Women with regular menstrual cycle (28 ±7) [14] for the last 3 months.
• Those fit for snehana and yoga.
• Those who provide informed consent.
 
 
ExclusionCriteria 
Details  • Those with history of psychiatric illness / on psychiatric medication
• Those with known pelvic pathologies
•Known cases of Cardio vascular diseases, Chronic hepatic diseases, Renal dysfunction, Thyroid dysfunction, Hyperlipidemia, Hypertension
•Lactating women
•Women on oral contraceptives and hormonal therapy
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
1. Participants advised to report on 1st,30th,60th,90th day
2. The data compiled using Premenstrual tension observer rating scale, Premenstrual symptom screening tool, Sheehan disability scale, Q-LES-Q-SF questionnaire Investigations.
4. asseesing the mental and physical health of participants
 		 1.Participants advised to report on 1st,30th,60th,90th day
2. The data compiled using Premenstrual tension observer rating scale, Premenstrual symptom screening tool, Sheehan disability scale, Q-LES-Q-SF questionnaire Investigations.
 
 
Secondary Outcome  
Outcome  TimePoints 
nil  nil 
 
Target Sample Size   Total Sample Size="16"
Sample Size from India="16" 
Final Enrollment numbers achieved (Total)= "16"
Final Enrollment numbers achieved (India)="16" 
Phase of Trial   N/A 
Date of First Enrollment (India)   10/07/2023 
Date of Study Completion (India) 23/05/2024 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
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
Modification(s)  

             Five percent of women have severe premenstrual symptoms and impairment of functioning defined as premenstrual dysphoric disorder (PMDD). The burden of illness of PMDD includes disruption of parenting and partner relationships and decreased productivity in work roles. In addition, women with PMDD have increased use of health care services such as clinician visits and increased use of medications. The aetiology of PMDD is multifactorial. In particular, dysregulation of the serotonin and allopregnanolone systems is implicated. Several effective treatment options exist, including serotonergic antidepressant medications and an oral contraceptive that contains ethinyl estradiol and drosperinone. In addition, other hormones that suppress ovulation, anxiolytics, cognitive therapy, and calcium  supplementation  are reported as helpful.  Several women report weight gain and sexual dysfunction after long-term antidepressant and hormonal use for PMDD

 PMDD is listed in the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) as a separate entity under Depressive disorders. Kalyānaka ghá¹›ta is a formulation from Ayurvedic classics used in psychiatric diseases and also observed as effective in reproductive domain. It is mentioned by Aacaarya Vaagbhat’a in Unmaada prathishedha. Previous studies have pointed out the use of Kalyānaka ghá¹›ta for Snehapana in Depressive disorder. 

The holistic approach of yoga by considering ‘mind-body’ interactions makes it an effective and acceptable approach to manage stress and improve the quality of life. Previous studies point out effect of yoga in premenstrual symptoms.The purpose of the proposed study is to evaluate the role of  yoga protocol and Kalyānaka ghá¹›ta in PMDD and quality of life.               16 participants satisfying the inclusion criteria will be administered Kalyānaka ghá¹›ta  with the selected yoga protocol for 2 menstrual cycles and effect will be assessed with the assessment tools.The data will be analysed with adequate statistical tests.

 
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