FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2021/06/033977 [Registered on: 03/06/2021] Trial Registered Prospectively
Last Modified On: 01/06/2021
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Clinical Study To Evaluate The Efficacy Of Dahaprashamana Gana In The Management Of Vasomotor Symptoms In Perimenopause And Menopause 
Scientific Title of Study   A Randomized Controlled Clinical Study To Evaluate The Efficacy Of Dahaprashamana Gana In The Management Of Vasomotor Symptoms In Perimenopause And Menopause 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Aiswarya Venunadh 
Designation  P G Scholar 
Affiliation  Sri Sri College of Ayurvedic Science and Research 
Address  OPD No. 10, Department Of Prasuti Tantra And Stree Roga,Sri Sri College of Ayurvedic Science and Research, B.M. Kaval, Udayapura P.O., 21 KM, Kanakapura Rd, Bengalore, Karnataka 560082

Bangalore
KARNATAKA
560082
India 
Phone  9497231314  
Fax    
Email  aishu.venu.09@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Shruti S Patil 
Designation  Associate Professor, Department of Prasuti Tantra And Streeroga 
Affiliation  Sri Sri College of Ayurvedic Science and Research 
Address  OPD No. 10, Department Of Prasuti Tantra And Stree Roga,Sri Sri College of Ayurvedic Science and Research, B.M. Kaval, Udayapura P.O., 21 KM, Kanakapura Rd, Bengalore, Karnataka 560082

Bangalore
KARNATAKA
560082
India 
Phone  9886269111  
Fax    
Email  shrutivinsun@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Aiswarya Venunadh 
Designation  P G Scholar 
Affiliation  Sri Sri College of Ayurvedic Science and Research 
Address  OPD No. 10, Department Of Prasuti Tantra And Stree Roga,Sri Sri College of Ayurvedic Science and Research, B.M. Kaval, Udayapura P.O., 21 KM, Kanakapura Rd, Bengalore, Karnataka 560082

Bangalore
KARNATAKA
560082
India 
Phone  9497231314  
Fax    
Email  aishu.venu.09@gmail.com  
 
Source of Monetary or Material Support  
Sri Sri College of Ayurvedic Science and Research Hospital,Survey No.269/270, B.M. Kaval, Udayapura P.O., 21 KM, Kanakapura Rd, Bengalore, Karnataka 560082 
 
Primary Sponsor  
Name  Sri Sri College of Ayurvedic Science and Research Hospital 
Address  Sri Sri College of Ayurvedic Science and Research Hospital,Survey No.269/270, B.M. Kaval, Udayapura P.O., 21 KM, Kanakapura Rd, Bengalore, Karnataka 560082 
Type of Sponsor  Research institution and hospital 
 
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 Shruti S Patil  Sri Sri College of Ayurvedic Science and Research, Bangalore  OPD No. 10, Department of PG Studies in Prasuti Tantra and Stree Roga, Sri Sri College of Ayurvedic Science and Research, Bangalore,Survey No.269/270, B.M. Kaval, Udayapura P.O., 21 KM, Kanakapura Rd, Bengalore, Karnataka 560082
Bangalore
KARNATAKA 
9886269111

shrutivinsun@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Sri Sri Instuitional Ethical Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:E35||Disorders of endocrine glands in diseases classified elsewhere. Ayurveda Condition: RAJONASAH (KEVALAVATA),  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Dahaprashamana Gana Churna  Daahaprashamana gana churnam 6gm BD with warm water Time of administration- Before food Duration of treatment for above drug would be one month  
Comparator Agent  Vitamin E Capsule  Vitamin E capsule (200 IU) 1 BD with warm water. Time of administration- Before food Duration of treatment – 30 days  
 
Inclusion Criteria  
Age From  40.00 Year(s)
Age To  60.00 Year(s)
Gender  Female 
Details  a)Subjects aged between 40 to 60 years.
b)Subjects having vasomotor symptoms in perimenopause and menopause

 
 
ExclusionCriteria 
Details  a) Subject age less than 40 years and above 60 years
b) Hemoglobin less than 8 gram percentage.
c) Subject known case of or having history of coagulopathy.
d) Subjects with other systemic illness like Diabetes Mellitus, Hypertension, Thyroid irregularities, Cardiac diseases
e) Subjects having history of carcinoma/ diagnosed carcinoma
f) Any pre- existing psychological disorder.
 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Dahaprashamana gana churna is effective in vasomotor symptoms in perimenopause and menopause i.e. their will be reduction in hotflushes, night sweat,palpitation and anxiety  1st day, 30th day, 60th day 
 
Secondary Outcome  
Outcome  TimePoints 
Vitamin E capsule was proved to be effective in treating vasomotor symptoms, which will be assessed by the scales with vasomotor symptoms  1st day,30th day, 60th day 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
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 
Date of First Enrollment (India)   08/06/2021 
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="20" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   NIL 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

Menopause is a transitional phase marking the finale of the reproductive life of a woman. It is associated with complex changes in both physical and psychological aspects. The changes are chiefly classified as vasomotor, psychological, genital and urinary symptoms. Among these, vasomotor symptoms are hallmark of menopause affecting 75% of women and in this 25% are severely affected..Vasomotor symptoms of menopause are characterized by episodes of profuse hot flushes accompanied by sweating, experienced predominantly around the head, neck, chest and upper back. These symptoms are experienced by majority of women during menopausal transition and they are the most common and long lasting symptoms according to many cohort and cross sectional studies.

Following menopause hot flashes are still pervasive and are experienced by 50% to 85% of menopausal women. Study done in group of women living in Asia, the intensity of vasomotor symptoms was 58% of women surveyed in 2013. Among menopausal symptoms, vasomotor symptoms among women range from 30% to 80% and they are affecting quality of life too.

Contemporary science offers hormone therapy to ease menopausal symptoms. Hormone therapy carries increased risk of endometrial & breast cancer, thromboembolic disorders, biliary diseases, dementia, emotional changes. There is an increased rate of discontinuity of HRT among women. It is therefore necessary to introduce safe and effective medications for the management of the same.

The term for menopause in Ayurveda is “rajo nivruthi”. Ayurvedic literature has very little reference available about rajo nivruthi or menopause. The age of rajonivruthi is said to be around 50 years as per the classics and it is considered as a premonitory sign of jara in women. The vasomotor symptoms clearly indicate the involvement of dominant pitta dosha associated with vata. Hence a drug that pacifies pitta along with vata is considered for this study.

Dahaprashamana gana which has been explained in Charaka Samhitha Sutra sthana, denotes a group of medicinal plants, which has been indicated as useful in removing daha or burning sensation which is a direct manifestation of Pitta. The name is derived from the word daha, meaning burning sensation or internal heat and prashamana which can be translated as ”pacifying”. The gana contains a total ten drugs grouped together viz; laaja, chandana , kashmarya, madhuka, sharkara, nilotpala, usheera, shariba, guduchi and hreebera.

 
Close