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
|
|
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
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
(1) ICD-10 Condition:E35||Disorders of endocrine glands in diseases classified elsewhere. Ayurveda Condition: RAJONASAHÂ (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 nivruthiâ€. 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 â€pacifyingâ€. The gana contains a total ten drugs grouped together viz; laaja, chandana , kashmarya, madhuka, sharkara, nilotpala, usheera, shariba, guduchi and hreebera. |