| CTRI Number |
CTRI/2024/12/078417 [Registered on: 23/12/2024] Trial Registered Prospectively |
| Last Modified On: |
14/12/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Effect of Sakanjik Japakusum and Jyotismati Patra in Secondary Amenorrhea |
|
Scientific Title of Study
|
A clinical trial to evaluate the effect of Sakanjik Japakusum and Jyotismati Patra on Nastartava (Secondary Amenorrhea) |
| 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 Samruddhi Heramb Narawade |
| Designation |
PG Scholar, Department of Prasuti Tantra Evum Striroga |
| Affiliation |
Sri Jayendra Saraswathi Ayurveda College and Hospital, Chennai |
| Address |
Department of Prasuti Tantra Evum Striroga, OPD block,Sri Jayendra Saraswathi Ayurveda College and Hospital,Nazarathpet, Chennai.
Thiruvallur
TAMIL NADU
600123
India
Thiruvallur
TAMIL NADU
600123
India |
| Phone |
9309009899 |
| Fax |
|
| Email |
samruddhinarawade@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr L V Rathnakar |
| Designation |
Professor, Department of Prasuti Tantra Evum Striroga |
| Affiliation |
Sri Jayendra Saraswathi Ayurveda College and Hospital, Chennai |
| Address |
Department of Prasuti Tantra Evum Striroga, OPD block,Sri Jayendra
Saraswathi Ayurveda College and Hospital,Nazarathpet, Chennai.
Thiruvallur
TAMIL NADU
600123
India
Thiruvallur
TAMIL NADU
600123
India |
| Phone |
9840340826 |
| Fax |
|
| Email |
drlrathnakar@sjsach.org.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Samruddhi Heramb Narawade |
| Designation |
PG Scholar, Department of Prasuti Tantra Evum Striroga |
| Affiliation |
Sri Jayendra Saraswathi Ayurveda College and Hospital,chennai |
| Address |
Department of Prasuti Tantra Evum Striroga, OPD block,Sri Jayendra
Saraswathi Ayurveda College and Hospital,Nazarathpet, Chennai.
Thiruvallur
TAMIL NADU
600123
India
Thiruvallur
TAMIL NADU
600123
India |
| Phone |
9309009899 |
| Fax |
|
| Email |
samruddhinarawade@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sri Jayendra Saraswathi Ayurveda College and Hospital,nazarathpeth,chenni,Tamil nadu India-600123 |
|
|
Primary Sponsor
|
| Name |
Dr. Samruddhi Heramb Narawade |
| Address |
Room no 13 ,Department of Prasuti Tantra Evum Striroga, Sri Jayendra Saraswathi Ayurveda College and Hospital, Nazarathpet, Chennai.
Thiruvallur
TAMIL NADU
600123
India |
| Type of Sponsor |
Other [Self] |
|
|
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 Samruddhi Heramb Narawade |
Sri Jayendra Saraswathi Ayurveda College and Hospital |
Room no.13,Department of Prasuti Tantra Evam Striroga,Sri Jayendra
Saraswathi Ayurveda College and Hospital,Nazarathpet, Chennai.
Thiruvallur
TAMIL NADU
600123
India
Thiruvallur
TAMIL NADU |
9309009899
samruddhinarawade@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Sri Jayendra Saraswati Ayurveda College and Hospital (Department of Ayurveda of SCSVMV Deemed to be University) NAZARATHPET, CHENNAI- 600123 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:N911||Secondary amenorrhea. Ayurveda Condition: ARTAVADOSHAH/ARTAVADUSHTIH/RAJODOSHAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: sakanjik japakusum and jyotismati patra, Reference: Bhaishajya Ratnavali, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 1(g), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 90 Days, anupAna/sahapAna: Yes(details: -kanji), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
15.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
Patients of age group 15-40years.
- Diagnosed cases of PCOS with chronic anovulation
- Hypothyroidism, Increased prolactin levels
- Low, high or normal FSH level & LH level
- Eating disorders, Stress |
|
| ExclusionCriteria |
| Details |
Pregnancy
- Cushing syndrome
- Empty Sella
- Sheehan syndrome
- Abnormal karyotype
- Asherman syndrome
- Anatomical abnormalities |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Regularization and reappearance of menses within 90 days of treatment period |
90days ( Three consecutive menstrual cycles) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
appearance of regular , cyclic menses with normal growth and secondary sexual characteristics.relieves the symptoms of PCOS,regularies
the hormones, |
90 days |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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)
|
09/01/2025 |
| 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="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
|
Menarche is a precious milestone of puberty. Hypothalamo pituitary gonadal axis (HPO Axis) plays a main role in the regulation of the cyclical changes that happens in the female reproductive structures like uterus, ovaries, vagina etc. If the basic health of women governed by rasa dhatu is deteriorated then the upadhatu artava would also be influenced. There is mainly derangement of vata. Apana Vata is said to be the governing force of menstrual flow and vyana vayu is responsible for rasarakta chankramana. Vitiated Apana vayu and vyana vayu leads to hampering of their normal function.The Principle treatment of Nastartava - Samshodhana, Shaman in the form of Agneya Dravyas, use of Swayonivardhana Dravyas and Nidana Parivarjana". The selected drug for the study contains japakusum, jyotismati, and kanjika. Japakusum has kasaya, tikta rasa, katu vipak, sita virya & kaphapittasamak properties. jyotismati is tikshna gunatmak katu, tikta rasatmak, katu vipaki, ushna viryatmak, Medhya, & vatakaphasamak as well as artavajanaka . kanjika is amla rasatmak, ushna viryatmak, amla vipaki, laghu, tikshna gunatmak, vatakaphanasak and dahasamak. Nastartava is considered as amenorrhoea in modern science. In Nastartava there is obstruction of passage by doshas because of that obstruction women’s menstruation stops. The meaning of nasyati means artava does not end at all, it just doesn’t seem to be coming out. In Nastartava Artavavaha Strotas and artavavahidhamanis gets blocked by vitiated Vata and Kapha dosha which leads to artava adarshanam (Nastartava). Nastartava is also seen as one of the manifestation of yonivyapads like vandhya yonivyapad ,shandhi,arajaska and shushka yonivyapad. Sakanjik Japakusum along with Jyotishmati patra administered orally in form of vati which works on vitiated Dosha, Dhatu & established pathophysiology because of having Vata Kapha Shaman & Artava Janana properties which leads to Samrapti Vighatan and formation of Artava in the end. |