| CTRI Number |
CTRI/2024/06/068681 [Registered on: 11/06/2024] Trial Registered Prospectively |
| Last Modified On: |
09/06/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A Study to compare the effect of Nasya with Anutaila prepared using Rainwater and RO water in Hairfall or Khalitya. |
|
Scientific Title of Study
|
Randomized open labelled comaprative clinical study to evaluate the efficacy of Nasya with Anutaila prepared with rain water and ro water in Hairfall with special reference to Khalitya. |
| 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 Bhanushree S |
| Designation |
PG Scholar |
| Affiliation |
Sri Sri College Of Ayurvedic Science and Research |
| Address |
Room No-8,
Out patient Department of Panchakarma,
Sri Sri College Of Ayurvedic Science And Research Hospital,
21st K M,Kanakapura Road,Udayapura post,Bangalore
Bangalore KARNATAKA 560082 India |
| Phone |
8951912514 |
| Fax |
- |
| Email |
bhanushree122@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Madhushree H S |
| Designation |
Professor |
| Affiliation |
Sri Sri College Of Ayurvedic Science and Research |
| Address |
Room No-8,Out patient Department of Panchakarma,Sri Sri College Of Ayurvedic Science and Research Hospital,21st K M,Kanakapura Road,Udayapura post, Bangalore
Bangalore KARNATAKA 560082 India |
| Phone |
9916058006 |
| Fax |
- |
| Email |
drmadhushreehs@rediffmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Madhushree H S |
| Designation |
Professor |
| Affiliation |
Sri Sri College Of Ayurvedic Science and Research |
| Address |
Room No-8,Out patient Department of Panchakarma,Sri Sri College Of Ayurvedic Science and Research Hospital,21st K M,Kanakapura Road ,Udayapura post,Bangalore.
Bangalore KARNATAKA 560082 India |
| Phone |
9916058006 |
| Fax |
- |
| Email |
drmadhushreehs@rediffmail.com |
|
|
Source of Monetary or Material Support
|
| Room No-8 Out patient Department of Panchakarma,Sri Sri College Of Ayurvedic Science and Research Hospital,21st K M Kanakapura Road Udayapura post ,Bangalore,Karnataka -560082,India. |
|
|
Primary Sponsor
|
| Name |
Dr Bhanushree S |
| Address |
Sri Sri College Of Ayurvedic Science and Research,Bangalore. |
| 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 Bhanushree S |
Sri Sri College Of Ayurvedic Science And Research Hospital |
Room No-8,Out patient Department of Panchakarma, 21st K M, Kanakapura Road, Udayapura post ,Bangalore,Karnataka -560082,India. Bangalore KARNATAKA |
8951912514
bhanushree122@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SRI SRI INSTITUTIONAL ETHICAL COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Complaints of hairfall |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Procedure | - | nasyam/ nastam, नसà¥à¤¯à¤®à¥/ नसà¥à¤¤à¤®à¥ | (Procedure Reference: Astanga hrudaya sutrasthana 20th chapter , Procedure details: POORVAKARMA 1)The subject will be advised to lie down in supine position with extended hands & legs with palms facing upwards, after passing the natural urges.2)Mrudu Abhyanga will be done with Moorchita Tila Taila on forehead, face & neck.3)Thick towel will be dipped in hot water, excess water will be squeezed out, then Tapa Sweda will be given to the face & neck region.4)Positioning of the subject will be done on the Droni, by raising the foot end and extending the neck by keeping single rolled towel below the shoulder.5)Eyes will be covered with wet cotton pads.6)Oil for Nasya will be warmed indirectly over hot water bath. PRADHANA KARMA 1)Tip of nose will be retracted with index finger of the left hand of therapist. 2)With right hand, warmed Anutaila prepared with RO water which is collected in Gokarna will be instilled into each nostril equally in Avicchinna Dhara, keeping the other nostril closed. 3)Thereafter subject will be instructed to inhale deeply and to spit out as and when the Dravya reaches to the throat PASCHAT KARMA 1)The subject will be asked to lie down for 100 Matra Kala.2)Dhooma Pana will be given with Haridradi Dhooma Varthi.3)Sukhoshna jala with a pinch of Saindhava Lavana will be given for Kavala.) (1) Medicine Name: Anutaila prepared with RO water , Reference: Astanga hrudaya sutrasthana 20th 37-39th sloka, Route: Nasal, Dosage Form: Bindu/ Drops/ Spray (Karna/ Nasa/ Netra/ Mukha), Dose: 4(ml), Frequency: od, Duration: 7 Days | | 2 | Intervention Arm | Procedure | - | nasyam/ nastam, नसà¥à¤¯à¤®à¥/ नसà¥à¤¤à¤®à¥ | (Procedure Reference: Astanga hrudaya sutrasthana 20th chapter , Procedure details: POORVAKARMA 1)The subject will be advised to lie down in supine position with extended hands & legs with palms facing upwards, after passing the natural urges.2)Mrudu Abhyanga will be done with Moorchita Tila Taila on forehead, face & neck.3)Thick towel will be dipped in hot water, excess water will be squeezed out, then Tapa Sweda will be given to the face & neck region.4)Positioning of the subject will be done on the Droni, by raising the foot end & extending the neck by keeping single rolled towel below the shoulder.5)Eyes will be covered with wet cotton pads.6)Oil for Nasya will be warmed indirectly over hot water bath. PRADHANA KARMA 1)Tip of nose will be retracted with index finger of the left hand of therapist. 2)With right hand, warmed Anutaila prepared with Rain water which is collected in Gokarna will be instilled into each nostril equally in Avicchinna Dhara, keeping the other nostril closed. 3)Thereafter subject will be instructed to inhale deeply & to spit out as and when the Dravya reaches to the throat PASCHAT KARMA 1)The subject will be asked to lie down for 100 Matra Kala.2)Dhooma Pana will be given with Haridradi Dhooma Varthi.3)Sukhoshna jala with a pinch of Saindhava Lavana will be given for Kavala.) (1) Medicine Name: Anutaila prepared with Rain water, Reference: Astanga hrudaya sutrasthana 20th chapter 37-39th sloka, Route: Nasal, Dosage Form: Bindu/ Drops/ Spray (Karna/ Nasa/ Netra/ Mukha), Dose: 4(ml), Frequency: od, Duration: 7 Days |
|
|
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Inclusion Criteria
|
| Age From |
21.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
1)Subjects in between the age group of 21 – 45years.
2)Subjects who complain of shedding of scalp hairs.
3)Subjects of either gender who are Nasya Yogyas according to Ayurveda classics irrespective of their occupation and socio-economic status.
4)Subjects who are willing to give a written consent for the treatment.
|
|
| ExclusionCriteria |
| Details |
1)Subject who are undergoing hair treatment, chemotherapy, radiation therapy.
2)Pregnant and lactating women.
3)Subjects unfit for Nasya Karma.
4)Subjects having any active scalp disease, Androgenetic alopecia, Alopecia areata and hair transplant.
5)Subjects with any known history systemic diseases and nutritional deficiencies which interfere treatment protocol and intervention.
6)Subjects of chronic alcoholic and psychiatric illness.
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Hairfall rate,60 sec haircount, Hair pull test,Trichoscopy findings(if required). |
Oth day,7th day,14th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
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 3 |
|
Date of First Enrollment (India)
|
30/07/2024 |
| 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="1" 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
|
Good-looking and attractive hair is a person’s natural jewellery, In today’s beauty concerned world, overlook of hair becomes a prime and important factor. Around 70% of men may experience hair loss in their lifetime, compared to only 40% of women. In Ayurvedic science, increased falling of hair is termed as Khalitya i.e.Khalati Skalayanti Kesa Asmatha .Ayurveda mentions, to obtain Arogya,Aishwarya, Yasha in the Loka, one should abide the lifestyle mentioned in the context of Dinacharya and Rutucharya. In the context of Dinacharya, Acharya has mentioned procedures like Moordhni Taila,Nasya(Pratimarsha variety),Snana etc.which can be taken into consideration for importance in the prevention of Khalitya. Acharya Charaka has mentioned Kesha as a Mala of Asthi Dhatu along with Vata Dosha predominance, and according to Acharya Sharngadhara it is a Upadhatu of Majja Dhatu. In general, one can lose up to 50 to 100 hairs per day, if the cycle is disrupted or a follicle is damaged, hair may begin to fall out more quickly. Due to changes in the lifestyle in contributes with the role of pollutants, climatic variation, stress, anxiety, work pressure, sedentary life style, improper care of the health, genetics etc., is intensifying the hair fall problems of the society in the early stage of individual’s life i.e., 20s and 30s. In contemporary science, the treatment protocol mentioned for hair loss is based on underlying conditions and nutritional supplements, with hair serum, platelet rich plasma technique, hair transplant etc. which has limitations due to its side effects and may not be feasible for everyone. Hence, it is necessary to conduct a study which would be helpful to manage hair fall with no side effects when compared to the available contemporary treatments. Nasya karma is one among the panchakarma where Aushadha is administered through nasal route, nourishes the Shiras, Skandha, Greeva and Urdhwajatrupradesha. Acharya Sushruta mentions“Khalitya Cha Api Asambhavah†this unmasks the importance of Nasya Karma in the Khalitya. According to Acharya Charaka, Dehoshma along with Vatadi Dosha causes Khalitya. Nasya with Sneha Dravya due to its Guna and Karma will pacify the vitiated Vata Dosha and provides the nourishment to the Shiras. In Charaka Samhita, Acharya has mentioned the importance of Anutaila as “Na Cha Kesha Pramuchyante Vardhante Cha Visheshatah†i.e., it prevents the falling of hairs as well as promotes the healthy growth of the hairs. Also, Acharya Vagbhata mentioned, Anatariksha Jala as Amrutopamam with Jeevana and Tarpana Guna. But at present, in the Pharmacy available formulation, Anatariksha Jala is replaced with RO water as we have room to build up various sources to procure water, which may have various significance on preparation. Hence, an attempt is made to study and compare the efficacy of Nasya with Anutaila prepared with Rain water and RO water in the management of Hairfall(Khalitya). |