| 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
|
|
|
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
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:N970||Female infertility associated withanovulation. Ayurveda Condition: VANDHYA, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm (Non Ayurveda) | | - | Tablet Clomiphene Citrate | Administration 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
| | 2 | Intervention Arm | Drug | Classical | | (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…….â€
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. |