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CTRI Number  CTRI/2024/10/075753 [Registered on: 23/10/2024] Trial Registered Prospectively
Last Modified On: 28/09/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Comparison between Rasona Ksheerapaka and Clomiphene Citrate in the treatment of infertility due to anovulation 
Scientific Title of Study   Evaluation of comparative efficacy of Rasona Ksheerapaka versus Clomiphene Citrate in the management of anovulation induced infertility - RCT 
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 Varsha P Jadhao 
Designation  Professor 
Affiliation  MGACHRC, Salod, Wardha, Maharastra 
Address  MANSAROVAR AYURVEIC MEDICAL COLLEGE, HOSPITAL AND RESEARCH CENTRE, BHOPAL
103,Danish kunj-5, KOLAR ROAD, BHOPAL
Bhopal
MADHYA PRADESH
462042
India 
Phone  9762780280  
Fax    
Email  drvarshapadhav@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  DR Varsha P Jadhao 
Designation  Professor 
Affiliation  MGACHRC, Salod, Wardha, Maharastra 
Address  MANSAROVAR AYURVEDIC MEDICAL COLLEGE, HOSPITAL AND RESEARCH CENTRE, BHOPAL
103,Danish kunj-5, KOLAR ROAD, BHOPAL
Bhopal
MADHYA PRADESH
462042
India 
Phone  9762780280  
Fax    
Email  drvarshapadhav@gmail.com  
 
Details of Contact Person
Public Query
 
Name  DR Varsha P Jadhao 
Designation  Professor 
Affiliation  MGACHRC, Salod, Wardha, Maharastra 
Address  MANSAROVAR AYURVEDIC MEDICAL COLLEGE, HOSPITAL AND RESEARCH CENTRE, BHOPAL
103,Danish kunj-5, KOLAR ROAD, BHOPAL
Bhopal
MADHYA PRADESH
462042
India 
Phone  9762780280  
Fax    
Email  drvarshapadhav@gmail.com  
 
Source of Monetary or Material Support  
Mahatma Gandhi Ayurvedic college Hospital And Research Centre , Datta Meghe Institute Of Higher Education And Research, Wardha, Maharashtra 
 
Primary Sponsor  
Name  MGACHRC, SALOD, WARDHA 
Address  MGACHRC, SALOD, WARDHA 
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 
DRPRATIKSHA RATHOD  MGACHRC  SALOD,WARDHA
Wardha
MAHARASHTRA 
9284295220

pudgal9@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUITIONAL ETHICS COMMITTEE, MGACHRC, SALOD, WARDHA  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:N970||Female infertility associated withanovulation. Ayurveda Condition: VANDHYA,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Comparator Arm (Non Ayurveda)-Tablet Clomiphene CitrateAdministration mode - Oral Period - from 2nd day of menstrual cycle Dosage - 50 mg once a day Course Length - 5 successive days in a month for consecutive 3 menstrual cycles
2Intervention ArmDrugClassical(1) Medicine Name: Rasona Siddha Ksheer, Reference: Kashyapa Samhita Rasonakalpa Adhyaya, Route: Oral, Dosage Form: Ksheerpaka, Dose: 40(ml), Frequency: od, Bhaishajya Kal: Abhakta, Duration: 10 Days, anupAna/sahapAna: No, Additional Information: -
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  35.00 Year(s)
Gender  Female 
Details  1 Patients of primary or secondary infertility due to anovulation or delayed ovulation
2 Patients having PCOD (Hyperandrogenic ovulatory dysfunction)
3 Irregular or scanty menses due to anovulatory cycle 
 
ExclusionCriteria 
Details   Unmarried patients non-fertile age group patients
 Bleeding P/V
 Carcinoma of cervix, Vaginal polypoid growth
 Diagnosed patients of fibroids in uterus
 Inborn genital tract abnormality
 Endometritis due to tubercular infection
 HIV/VDRL/HbsAg positive
 Diagnosed subjects for malignancy
 Patients on hormonal treatment
 Non-Cooperative patients
 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
To evaluate the ovulatory effects of trial drug
To predict possible mode of action of trial drug on anovulatory menstrual cycle
 
120 days 
 
Secondary Outcome  
Outcome  TimePoints 
To provide herbal cost effective better alternative in the management of anovulation in the patients of infertility
To observe adverse drug reactions of trial drug if any during the trial & follow up period
 
120 days 
 
Target Sample Size   Total Sample Size="66"
Sample Size from India="66" 
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)   05/11/2024 
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="2"
Months="0"
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  

“A women’s life is incomplete without her being transformed into a mother…….”

Many of us may claim that this quote is not universal. Although, one cannot deny that being a mother is dream of most of the women.

Failing to ovulate has become one of the commonest cause of infertility. Clomiphene Citrate has become popular for the condition. However, it has shown potent results, it also has numerous side effects such as ovarian hyper stimulation syndrome, ovarian cyst, multiple pregnancies and resistance to treatment etc. On the other hand, it doesn’t work on womb preparation and hence patient have to consume estrogens which possess other adverse effects. Due to such reasons patients with anovulation are eventually left with the only option to opt for IVF (In Vitro Fertilization) which cannot be afforded by everyone. Here, Ayurveda can be savior for such patients, as Acharya Kashyapa has elaborated use of Rasona in patients with Beej related diseases1.

Among the causes of female infertility, anovulation is becoming commoner and shares about 25% of prevalence. One can say that every female encounter anovulation at some times during her fertile age2. Clomiphene Citrate remains the drug of choice in modern medicine for those who does not respond to hormone therapy regimen. Approximately, 50 – 80 % women ovulate after taking clomiphene citrate but the pregnancy rate is nearly half of the ovulation.

          Classical Ayurvedic literature has numerous references which can be co-related with the said entity, viz; Beejopaghata, Pushpopaghata, Abeeja etc. Acharya Kashyapa has claimed that Rasona has Shonitajanana properties which is nothing but Stribeeja (i.e. ovum) and also supports growth of Garbha3. He has devoted a whole chapter in his Samhita for use of Rasona in management of Vandhyatva. He has described many formulations of Rasona in combination with various drugs. It is also beneficial for prevention of menstrual diseases, pelvic disorders and infertility too4. Acharya Kashyapa has recommended use of Rasona in various forms such as crude garlic bulbs fried in ghee, in the form of dumplings made from different vegetables leaves, meats, Yawagu, curds, etc. treated with Rasona. Besides these oral preparations, he has recommended use of Ghrita, Taila, etc. medicated with Rasona for oral use and Basti also5. In short Acharya Kashyapa has acclaimed to use Rasona in various forms or formulations or routes, that’s why in this study scholar is intended to study use of Rasona Ksheerapaka in female infertility.

          In the previous study conducted by the scholar in 2009, Rasona Tail Uttarbasti (intra uterine instillation of oil) and Rasona Sidhha Ksheera were compared with Clomiphene Citrate and it was evidenced that the trial group was effective in regularizing the menstrual cycle, timely ovulation and increasing endometrial thickness6.      

          Hence to evaluate the ovulatory properties of Rasona Ksheerapaka in anovulatory cycles this study is planned. The sample size will be divided in two equal groups, Group A will be administered with Rasona Ksheerapaka and Group B will be administered with Clomiphene Citrate.

 
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