FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2026/01/101323 [Registered on: 16/01/2026] Trial Registered Prospectively
Last Modified On: 19/01/2026
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda
Screening
Other (Specify) [Yashtimadhu churna orally with Bala Taila yoni pichu]  
Study Design  Single Arm Study 
Public Title of Study   Role of Ayurvedic Medicines in Managing Menopausal Problems  
Scientific Title of Study   An open labelled single arm clinical study to evaluate the efficacy of Yashtimadhu churna orally along with Bala Taila yoni pichu in menopause 
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 Hardi Joshi 
Designation  PG Scholar 
Affiliation  Shree Swaminarayan Ayurvedic college and hospital Kalol 
Address  Department of Prasuti Tantra evum Stree Roga Shree Swaminarayan Ayurvedic college and hospital Kalol Shree Swaminarayan Ayurvedic college and hospital Kalol Gandhinagar
Department of Prasuti Tantra evum Stree Roga Shree Swaminarayan Ayurvedic college and hospital Kalol Shree Swaminarayan Ayurvedic college and hospital Kalol Gandhinagar
Gandhinagar
GUJARAT
382725
India 
Phone  6353690007  
Fax    
Email  joshihardi0@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Ranjana Ingale 
Designation  HOD & Prof PTSR Dept 
Affiliation  Shree Swaminarayan Ayurvedic College and Hospital Kalol 
Address  Department of Prasuti Tantra evum Stree Roga Shree Swaminarayan Ayurvedic college and hospital Kalol Shree Swaminarayan Ayurvedic college and hospital Kalol Gandhinagar
Department of Prasuti Tantra evum Stree Roga Shree Swaminarayan Ayurvedic college and hospital Kalol Shree Swaminarayan Ayurvedic college and hospital Kalol Gandhinagar
Gandhinagar
GUJARAT
382725
India 
Phone  9909945110  
Fax    
Email  ranjanaingale7396@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Hardi Joshi 
Designation  PG Scholar 
Affiliation  Shree Swaminarayan Ayurvedic College and Hospital Kalol 
Address  Department of Prasuti Tantra evum Stree Roga Shree Swaminarayan Ayurvedic college and hospital Kalol Shree Swaminarayan Ayurvedic college and hospital Kalol Gandhinagar
Department of Prasuti Tantra evum Stree Roga Shree Swaminarayan Ayurvedic college and hospital Kalol Shree Swaminarayan Ayurvedic college and hospital Kalol Gandhinagar
Gandhinagar
GUJARAT
382725
India 
Phone  6353690007  
Fax    
Email  joshihardi0@gmail.com  
 
Source of Monetary or Material Support  
Shree Swaminarayan Ayurvedic College and Hospital Ahmedabad Mehsana Highway at PO Saij Ta Kalol Dist Gandhinagar 382725 Gujarat 
 
Primary Sponsor  
Name  Shree Swaminarayan Ayurvedic and Hospital  
Address  Faculty of Ayurveda Shree Swaminarayan Ayurvedic College Ahnedabad Mehsana Highway AT PO Saij Ta Kalol Dist Gandhinagar 382725 Gujarat India 
Type of Sponsor  Private medical college 
 
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 Hardi Joshi  Premswarup Swami Ayurvedic Multispeciality Hopsital   OPD 001 Department of Prasuti Tantra Evum Stree Roga Premswarup Swami Ayurvedic multispeciality Hospital Ahmedabad Mehsana Highway At Po Saij Ta Kalol Dist Gandhinagar 382725 Gujarat
Gandhinagar
GUJARAT 		 6353690007

joshihardi0@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
SWAMINARAYAN UNIVERSITY INSTITUTIONAL ETHICS COMMITTEE FOR HUMAN RESEARCH  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: N951||Menopausal and female climactericstates,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  NIL  NIL 
Intervention  Yashtimadhu churna orally along with Bala Taila yoni pichu  Yashtimadhu churna 3 gm orally with uahna dugdha for 2 months and with Bala Taila yoni pichu for 7 days for 2 consecutive months 
 
Inclusion Criteria  
Age From  45.00 Year(s)
Age To  55.00 Year(s)
Gender  Female 
Details  Women aged 45 to 55 years
Based on menopause rating scale
Symptoms of irritability, mood swings , hot flushes, anxiety, loss of
concentration, sleep changes, lack of interest in usual activities, irrational
thoughts and over sensitive
Patients with physiological menopause
Patients who have not attained menses for more than a period of 1 year
Patients who are willing to give their consent to participate in the study 
 
ExclusionCriteria 
Details  Age of patient leas than 45 years and above 55 years
Patient taking HRT
Anemic condition (Hb less than 9gm%)
K/C/O Chronic progressive illness such as HIV, HBsAg and Malignancy
K/C/O uncontrolled medical conditions such as Hypertension, Type 1 and Type
2 Diabetes, Thyroid Dysfunction, Cardiovascular disease, Cerebrovascular
disease, Coronary artery disease, Pulmonary Dysfunction
Patient who have achieved pathological menopause like hysterectomy or
bilateral oopherectomy
Patient with abnormal menopause, surgical and delayed/ late menopause
The patient is participating in another research study within 6 months
Patient who is not willing to sign the consent form 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To assess the effect of Yashtimadhu churna and Bala Taila Yoni Pichu in
menopause.
 		 every month 
 
Secondary Outcome  
Outcome  TimePoints 
• To evaluate dietary and life style changes after use of Yashtimadhu churna
orally and Bala Taila Yoni Pichu in menopause. 		 every month 
 
Target Sample Size   Total Sample Size="50"
Sample Size from India="50" 
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)   27/01/2026 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  27/01/2026 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="2"
Months="0"
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   Menopause is permanent cessation of menstruation for 12 months resulting from the loss of ovarian and follicular activity. The mean age of menopause is 50 years and is mainly determined genetically. Menopausal age is not related to menarche, socioeconomic status, number of pregnancies, lactation, and use of OCP. Smoking induces premature menopause. The pre-menopause refers to period prior to menopause, post-menopause to period after menopause and perimenopause to period around menopause. Perimenopause is the part of the climacteric when the menstrual cycle is likely to be irregular. Menopausal transition, also known as perimenopause, is the period of the ageing process in which a woman goes from a reproductive to a non- reproductive stage. It is the time period between the late reproductive years, which is generally between the late 40s and the early 50s. It begins with irregular menstrual cycles and lasts for one year following menstruation cessation. Perimenopause culminates with menopause, when menses have ceased for a period of at least 12 consecutive months.. By following Ayurvedic principles will help to eradicate the depressing negative impacts associated with menopause. This will make her menopausal transition time more pleasant. It is also imperative for us to verify the properties of mentioned drug using scientific tools. Investigating its potential as a Rasayana during this transitional phase may provide valuable insights into its role in improving quality of life, hormonal balance and overall health. As a result, there is growing interest in exploring alternative and holistic approaches that can support overall health without causing harmful side effects. Ayurveda, the ancient Indian system of medicine offers a unique perspective which focuses on rejuvenation, longevity, and maintaining balance in body and mind[10]. Research on menopausal symptoms is important in improving well being and overall health of women. Hormone replacement therapy is the only treatment adopted by modern medicine which has a wider range of side effects. Hence a study on menopausal symptoms is the need of the day. Therefore, this study is essential to scientifically assess the effectiveness of Yashtimadhu churna orally and Bala Taila Yoni Pichu in managing menopausal symptoms The findings may contribute to the development of safe, natural, and holistic options for women’s healthcare during midlife transitions, while also supporting the integration of Ayurvedic principles into contemporary health practices. 
Close